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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-3647

2. Registrant Information.

Registrant Reference Number: Prosar case 1-16114813

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.

07-MAY-08

5. Location of incident.

Country: UNITED STATES

Prov / State: OREGON

6. Date incident was first observed.

07-MAY-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. 2724-734-2596

Product Name: UltraGuard Ear Mite Treatment for Cats

  • Active Ingredient(s)
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration .5 %
    • PYRETHRINS
      • Guarantee/concentration .05 %

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 instilled the product in her cat's ears on 5/4/08.

To be determined by Registrant

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

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Kitten, unknown breed

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

0

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Reproductive System
    • Symptom - Stillborn infant

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?

Other / Autre

specify Kitten was born dead. Exposure to product through systemic absorption is an unlikely route of exposure.

17. Provide any additional details about the incident

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

1-16114813: The reporter called on 5/7/08 to report she had instilled a topical ear mite treatment containing the active ingredients Pyrethrins and Piperonyl Butoxide into her cat's ears on 5/4/08. At the time of the call, the cat had given birth to several kittens that day, one of whom had been born dead. The reporter had not known that the cat had been pregnant when she had used the drops. She inquired regarding the possibility that the product contributed to the kitten's death, and whether or not the surviving kittens needed to be bottle-fed. The safety profile of the product was discussed, including the fact that systemic absorption would have been unlikely. A recommendation was made to consult the reporter's veterinarian regarding bottle-feeding. It was also discussed that the product is not recommended for use on pregnant or nursing animals.


To be determined by Registrant

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

Death

19. Provide supplemental information here