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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-4143

2. Registrant Information.

Registrant Reference Number: PROSAR Case 1-16489504

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

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.

05-AUG-08

5. Location of incident.

Country: UNITED STATES

Prov / State: INDIANA

6. Date incident was first observed.

03-AUG-08

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 and Tick Drops for Dogs and Puppies 4-15lbs

  • 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 reporter applied product intended for dogs weighing 4-15lbs to a 30lb dog on 8/3/2008.

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

Other

2. Type of animal affected

Dog / Chien

3. Breed

Collie Mix

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.38

7. Weight (provide a range if necessary )

30

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>15 min <=2 hrs / >15 min <=2 h

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

  • General
    • Symptom - Lethargy
  • Nervous and Muscular Systems
    • Symptom - Difficulty getting up
    • Specify - Unable to stand
  • Gastrointestinal System
    • Symptom - Diarrhea
  • 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

1-16489504: The reporter called on 8/5/2008 to report exposure of a rescue puppy to a flea and tick product containing the active ingredient Phenothrin. According to the reporter, she applied product labeled for a 4lb to 15lb dog on a 30lb rescue puppy on 8/3/2008. The reported stated that she used this strength product as the puppy had not been exposed to any flea products previously. At the time of application, the puppy did not appear to have any fleas and the product was being use as a prophylaxis. The puppy had been at the animal shelter for one month, was healthy, current on vaccines, had been de-wormed and had experienced no previous problems while at the shelter. One hour after product administration, the puppy was lethargic. The reporter gave the dog a bath with dish soap and rinsed the dog with water. Forty minutes later the dog was unable to stand and then died. At the time of death the dog had brown diarrhea. No CNS signs were noted prior to the dog┐s death. The safety profile of the product was discussed including the fact that the product has a low level of toxicity and wide margin of safety in dogs and puppies and the symptoms described would not be expected with product use.


To be determined by Registrant

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

Death

19. Provide supplemental information here