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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-0864

2. Registrant Information.

Registrant Reference Number: PROSAR 1-21432461

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-JAN-10

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

23-JAN-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. 26491      PMRA Submission No.       EPA Registration No.

Product Name: UltraGuard One Spot Treatment for Cats/Kittens (Canada)

  • Active Ingredient(s)
    • (S)-METHOPRENE

PMRA Registration No.       PMRA Submission No.       EPA Registration No.

Product Name: Non-specific Large Animal Ivermectin

  • Active Ingredient(s)

7. b) Type of formulation.

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).

Two doses of the product were applied to the cat, one right after the other, on 01/23/2010. The cat also ingested an unknown amount of non-specific large animal ivermectin at an unknown time. NOTE: This product is not labeled to be applied more frequently than once dose once a month.

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

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

2

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 - Difficulty walking
    • Symptom - Seizure
    • Symptom - Unresponsive
    • Specify - "non-responsive"

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

1-21432461: A reporter (veterinary technician) called on 01/25/2010 to report the exposure of a cat to a flea egg and larvae product containing the active ingredient Methoprene. According to the reporter, 2 doses of the product were applied to the cat, one after the other, on 01/23/2010. Within 15 minutes, the cat was having difficulty walking. On 01/24/2010, the cat began having seizures which persisted until the cat presented to the veterinary clinic on 01/25/2010. At the time of the report, the cat had been given Valium to control the seizures. The reporter stated that a dog does live in the household, but it was not treated recently with any flea and tick products. The reporter was advised that the product contains Methoprene, which has little to no mammalian toxicity and adverse effects are not expected following routine use. A recommendation was made to bathe the cat in a non-insecticidal shampoo and rule out other causes for the signs. On follow up on 01/26/2010, a veterinary clinic employee stated that the cat had ingested an unknown amount of large animal ivermectin at an unknown time. The signs were being attributed to that ingestion, and not to the flea egg and larvae product. At the time of the follow up, the cat was non-responsive and the owners were considering euthanasia. No further information was obtained. NOTE: This product is not labeled to be applied more frequently than once dose once a month.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here