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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-5499

2. Registrant Information.

Registrant Reference Number: PROSAR Case #1-24215638

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.

27-SEP-10

5. Location of incident.

Country: UNITED STATES

Prov / State: NORTH CAROLINA

6. Date incident was first observed.

24-SEP-10

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 4-15 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).

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

unknown

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.19

7. Weight (provide a range if necessary )

12

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>3 days <=1 wk / >3 jours <=1 sem

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Ataxia
    • Symptom - Muscle tremors
  • Respiratory System
    • Symptom - Panting
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

No

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

1-24215638- The reporter, a pet owner, indicates his animal was exposed to a pesticide containing the active ingredient phenothrin. The caller reports he applied the product, a topical flea and tick drop labeled for dogs, to his two ten week puppies (one female one male) six days prior to the initial contact with the registrant. The eight pound female animal (Sub-form III, #2) developed ataxia, muscle tremors, and panting three days following application. The animal was brought to the veterinarian bathed, given fluids, and supported. The owner¿s twelve pound male dog (Sub-form III, #1) developed the same signs one day later. The animal was bathed numerous times at home but never brought to the veterinarian. The animal died later in the day. The animal that died had been buried prior to necropsy. The owner was advised the product was labeled for animal 12 weeks and older. Despite misuse of the product the signs seen would not be expected. The caller was advised of supportive measures typically used following veterinary pyrethroid exposures and to work further with the veterinarian to determine the cause of the signs seen. On routine call back the pet owner advised the registrant that the female animal had been released from the veterinarian¿s office recovered. The caller indicated the veterinarian stated the product was responsible for the signs seen, but did not indicate how that diagnosis was arrived at. No further information is available.


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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Unknown

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.19

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

>3 days <=1 wk / >3 jours <=1 sem

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Ataxia
    • Symptom - Muscle tremors
  • Respiratory System
    • Symptom - Panting

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

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

1-24215638- The reporter, a pet owner, indicates his animal was exposed to a pesticide containing the active ingredient phenothrin. The caller reports he applied the product, a topical flea and tick drop labeled for dogs, to his two ten week puppies (one female one male) six days prior to the initial contact with the registrant. The eight pound female animal (Sub-form III, #2) developed ataxia, muscle tremors, and panting three days following application. The animal was brought to the veterinarian bathed, given fluids, and supported. The owner¿s twelve pound male dog (Sub-form III, #1) developed the same signs one day later. The animal was bathed numerous times at home but never brought to the veterinarian. The animal died later in the day. The animal that died had been buried prior to necropsy. The owner was advised the product was labeled for animal 12 weeks and older. Despite misuse of the product the signs seen would not be expected. The caller was advised of supportive measures typically used following veterinary pyrethroid exposures and to work further with the veterinarian to determine the cause of the signs seen. On routine call back the pet owner advised the registrant that the female animal had been released from the veterinarian¿s office recovered. The caller indicated the veterinarian stated the product was responsible for the signs seen, but did not indicate how that diagnosis was arrived at. No further information is available.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here