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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-4005

2. Registrant Information.

Registrant Reference Number: Prosar 1-19630975

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.

25-AUG-09

5. Location of incident.

Country: UNITED STATES

Prov / State: MICHIGAN

6. Date incident was first observed.

23-AUG-09

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. 2596-151

Product Name: UltraGuard Flea/Tick Drops for Dogs/Puppies Over 60 lbs

  • Active Ingredient(s)
    • D-PHENOTHRIN
      • Guarantee/concentration 85.7 %

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).

The 2 dogs were bathed with an unknown shampoo on 08/20/2009. The topical drops were applied to both dogs on 08/21/2009.

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Boxer

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

10

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

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Seizure
    • Symptom - Ataxia
  • Cardiovascular System
    • Symptom - Bradycardia
  • 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?

No

14. b) How long was the animal hospitalized?

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

1-19630975: A reporter (veterinarian) called on 08/25/2009 to report the exposure of her 2 dogs to a flea and tick product containing the active ingredient Phenothrin. According to the reporter, the dogs were bathed with an unknown flea and tick shampoo on 08/20/2009. The topical product was applied to the dogs on 08/21/2009. On 08/23/2009, Dog #1 (1st Subform III) developed seizures. Dog #1 continued to have multiple seizures and presented to the veterinary clinic on 08/25/2009 with ataxia and bradycardia. The dog had been bathed by the owners prior to presentation. The reporter was advised that it is recommended to consult a veterinarian prior to using flea and tick products on older dogs. The reporter was also advised that layering of products can result in toxicity. A recommendation was made to bathe the dog in hand dish soap to remove any product residue. Symptomatic and supportive care including methocarbamol for tremors and phenobarbital for seizures should be instituted. Monitoring for resolution of symptoms at the veterinary clinic was recommended. On follow up on 08/26/2009, a veterinary clinic employee stated that the dog had been sent home and the owners called earlier to report that the dog had had several more seizures. On follow up on 08/28/2009, a veterinary clinic employee stated that the dog's owners reported that she died. The employee also stated that a second dog (2nd Subform III) was "affected" as well, but the employee did not report Dog #2's signs. Dog #2 was treated with atropine and bathed several times. The owners declined any further treatment. The owners reported that Dog #2 had recovered. No further information was obtained.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Boxer

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

7

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

  • General
    • Symptom - Other
    • Specify - Dog was "affected". Specific signs not reported.

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?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Fully Recovered / Complètement rétabli

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

1-19630975: A reporter (veterinarian) called on 08/25/2009 to report the exposure of her 2 dogs to a flea and tick product containing the active ingredient Phenothrin. According to the reporter, the dogs were bathed with an unknown flea and tick shampoo on 08/20/2009. The topical product was applied to the dogs on 08/21/2009. On 08/23/2009, Dog #1 (1st Subform III) developed seizures. Dog #1 continued to have multiple seizures and presented to the veterinary clinic on 08/25/2009 with ataxia and bradycardia. The dog had been bathed by the owners prior to presentation. The reporter was advised that it is recommended to consult a veterinarian prior to using flea and tick products on older dogs. The reporter was also advised that layering of products can result in toxicity. A recommendation was made to bathe the dog in hand dish soap to remove any product residue. Symptomatic and supportive care including methocarbamol for tremors and phenobarbital for seizures should be instituted. Monitoring for resolution of symptoms at the veterinary clinic was recommended. On follow up on 08/26/2009, a veterinary clinic employee stated that the dog had been sent home and the owners called earlier to report that the dog had had several more seizures. On follow up on 08/28/2009, a veterinary clinic employee stated that the dog's owners reported that she died. The employee also stated that a second dog (2nd Subform III) was "affected" as well, but the employee did not report Dog #2's signs. Dog #2 was treated with atropine and bathed several times. The owners declined any further treatment. The owners reported that Dog #2 had recovered. No further information was obtained.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here