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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-2336

2. Registrant Information.

Registrant Reference Number: 2020-US-000751

Registrant Name (Full Legal Name no abbreviations): The Hartz Mountain Corporation

Address: 400 Plaza Drive

City: Secaucus

Prov / State: New Jersey

Country: USA

Postal Code: 07094-3688

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

16-JAN-20

5. Location of incident.

Country: UNITED STATES

Prov / State: MISSOURI

6. Date incident was first observed.

15-JAN-20

Product Description

7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.

Active(s)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2596-153

Product Name: Hartz UltraGuard Rid Flea and Tick Shampoo with Oatmeal for Dogs

  • Active Ingredient(s)
    • D-PHENOTHRIN
      • Guarantee/concentration .27 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

10. Site pesticide was applied to (select all that apply).

Site: Animal / Usage sur un animal domestique

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

Please refer to field 13 on Subform II or field 17 of Subform III for a detailed description regarding application.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

English Bulldog

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.33

7. Weight (provide a range if necessary )

8

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Muscle weakness
    • Symptom - Seizure
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

1

Day(s) / Jour(s)

15. Outcome of the incident

Died

16. How was the animal exposed?

Treatment / Traitement

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

On 15-Jan-2020, the animal owner administered 1 application of Hartz UltraGuard Rid Flea and Tick Shampoo with Oatmeal for Dogs (Phenothrin) via the topical route, to four, 4 month old, English Bulldog puppies. This was an extra-label use as the product is not intended for use on dogs under 6 months of age. After product administration, the four puppies were also administered an unknown amount of an unspecified pet shampoo, via the topical route by the animal owner. Approximately 30 minutes post product administration, one approximately 8 pound, intact, male, English Bulldog dog, in unknown condition, with no known concomitant medical conditions, exhibited rear limb muscle weakness. The emergency veterinarian was called and they recommended continuing to monitor the dog. Approximately 1 hour post product administration, the dog developed multiple seizures. The emergency veterinarian was called and they recommended placing the puppy on a heating pad. The veterinarian had not been informed of product use at this time. The three other puppies exhibited vomiting post product administration, and one puppy also exhibited multiple seizures, loss of consciousness and stopped breathing multiple times. The animal owner brought all four puppies to the emergency veterinary facility and upon presentation, the pet owner informed the veterinarian of product use. All puppies were bathed with unspecified soap and administered IV fluids. Unspecified blood work was also performed on the approximately 8 pound, intact, male dog, but the lab results are unknown. The animal owner left the dogs at the emergency veterinary facility for continued treatment and monitoring. The animal owner was unaware of further treatments provided. On 16-Jan-2020, the puppy died at the veterinary facility and another puppy was not expected to survive. No further information regarding the puppies was received in this case.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

Assessment: The active ingredient in this product is present in low concentration and has a wide safety margin in dogs. Although the product was misused, rear limb weakness, seizures, and death are still not expected following use. The pet owner did not specify if other signs occurred during hospitalization prior to the dog's death. It was not reported if a necropsy was performed. Other causes should be considered in this case including underlying congenital defects, infectious diseases, toxin exposure, and trauma given the young age of the dog. The information contained in this report is based on self-reported statements provided to the registrant during telephone Interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and can not form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

specify Puppy

3. Breed

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Vomiting
  • Respiratory System
    • Symptom - Difficulty Breathing
    • Specify - Stopped breathing several times
  • Nervous and Muscular Systems
    • Symptom - Seizure
    • Specify - multiple
    • Symptom - Unconsciousness

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

Unknown

15. Outcome of the incident

Unknown/Inconnu

16. How was the animal exposed?

Treatment / Traitement

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

On 15-Jan-2020, the animal owner administered 1 application of Hartz UltraGuard Rid Flea and Tick Shampoo with Oatmeal for Dogs (Phenothrin) via the topical route, to four, 4 month old, English Bulldog puppies. This was an extra-label use as the product is not intended for use on dogs under 6 months of age. After product administration, the four puppies were also administered an unknown amount of an unspecified pet shampoo, via the topical route by the animal owner. Approximately 30 minutes post product administration, one approximately 8 pound, intact, male, English Bulldog dog, in unknown condition, with no known concomitant medical conditions, exhibited rear limb muscle weakness. The emergency veterinarian was called and they recommended continuing to monitor the dog. Approximately 1 hour post product administration, the dog developed multiple seizures. The emergency veterinarian was called and they recommended placing the puppy on a heating pad. The veterinarian had not been informed of product use at this time. The three other puppies exhibited vomiting post product administration, and one puppy also exhibited multiple seizures, loss of consciousness and stopped breathing multiple times. The animal owner brought all four puppies to the emergency veterinary facility and upon presentation, the pet owner informed the veterinarian of product use. All puppies were bathed with unspecified soap and administered IV fluids. Unspecified blood work was also performed on the approximately 8 pound, intact, male dog, but the lab results are unknown. The animal owner left the dogs at the emergency veterinary facility for continued treatment and monitoring. The animal owner was unaware of further treatments provided. On 16-Jan-2020, the puppy died at the veterinary facility and another puppy was not expected to survive. No further information regarding the puppies was received in this case.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Not Applicable

19. Provide supplemental information here

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

specify Puppy

3. Breed

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Vomiting

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

Unknown

15. Outcome of the incident

Unknown/Inconnu

16. How was the animal exposed?

Treatment / Traitement

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

On 15-Jan-2020, the animal owner administered 1 application of Hartz UltraGuard Rid Flea and Tick Shampoo with Oatmeal for Dogs (Phenothrin) via the topical route, to four, 4 month old, English Bulldog puppies. This was an extra-label use as the product is not intended for use on dogs under 6 months of age. After product administration, the four puppies were also administered an unknown amount of an unspecified pet shampoo, via the topical route by the animal owner. Approximately 30 minutes post product administration, one approximately 8 pound, intact, male, English Bulldog dog, in unknown condition, with no known concomitant medical conditions, exhibited rear limb muscle weakness. The emergency veterinarian was called and they recommended continuing to monitor the dog. Approximately 1 hour post product administration, the dog developed multiple seizures. The emergency veterinarian was called and they recommended placing the puppy on a heating pad. The veterinarian had not been informed of product use at this time. The three other puppies exhibited vomiting post product administration, and one puppy also exhibited multiple seizures, loss of consciousness and stopped breathing multiple times. The animal owner brought all four puppies to the emergency veterinary facility and upon presentation, the pet owner informed the veterinarian of product use. All puppies were bathed with unspecified soap and administered IV fluids. Unspecified blood work was also performed on the approximately 8 pound, intact, male dog, but the lab results are unknown. The animal owner left the dogs at the emergency veterinary facility for continued treatment and monitoring. The animal owner was unaware of further treatments provided. On 16-Jan-2020, the puppy died at the veterinary facility and another puppy was not expected to survive. No further information regarding the puppies was received in this case.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Not Applicable

19. Provide supplemental information here

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

specify Puppy

3. Breed

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Vomiting

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

Unknown

15. Outcome of the incident

Unknown/Inconnu

16. How was the animal exposed?

Treatment / Traitement

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

On 15-Jan-2020, the animal owner administered 1 application of Hartz UltraGuard Rid Flea and Tick Shampoo with Oatmeal for Dogs (Phenothrin) via the topical route, to four, 4 month old, English Bulldog puppies. This was an extra-label use as the product is not intended for use on dogs under 6 months of age. After product administration, the four puppies were also administered an unknown amount of an unspecified pet shampoo, via the topical route by the animal owner. Approximately 30 minutes post product administration, one approximately 8 pound, intact, male, English Bulldog dog, in unknown condition, with no known concomitant medical conditions, exhibited rear limb muscle weakness. The emergency veterinarian was called and they recommended continuing to monitor the dog. Approximately 1 hour post product administration, the dog developed multiple seizures. The emergency veterinarian was called and they recommended placing the puppy on a heating pad. The veterinarian had not been informed of product use at this time. The three other puppies exhibited vomiting post product administration, and one puppy also exhibited multiple seizures, loss of consciousness and stopped breathing multiple times. The animal owner brought all four puppies to the emergency veterinary facility and upon presentation, the pet owner informed the veterinarian of product use. All puppies were bathed with unspecified soap and administered IV fluids. Unspecified blood work was also performed on the approximately 8 pound, intact, male dog, but the lab results are unknown. The animal owner left the dogs at the emergency veterinary facility for continued treatment and monitoring. The animal owner was unaware of further treatments provided. On 16-Jan-2020, the puppy died at the veterinary facility and another puppy was not expected to survive. No further information regarding the puppies was received in this case.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Not Applicable

19. Provide supplemental information here