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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-1040

2. Registrant Information.

Registrant Reference Number: PROSAR Case # 1-24907086

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.

08-DEC-10

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

08-DEC-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 and Kittens (Canada)

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

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).

The cat's owner applied the product on 12/7/10. The cat's owners also have dogs, and applied an unknown brand of flea and tick topical drops to the dogs on 12/7/10 as well.

To be determined by Registrant

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

Yes

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

Male

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

8.36

lbs

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 - Ataxia
    • Symptom - Shaking
  • Gastrointestinal System
    • Symptom - Anorexia

12. How long did the symptoms last?

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

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?

48

Hour(s) / Heure(s)

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

1-24907086: The reporter, a veterinarian, called on 12/8/10 to report a reaction by a 3 year old female DSH after the cat had been exposed to a flea and tick product containing the active ingredient Methoprene. According to the reporter, the product had been applied on 12/7/10, and the cat had presented on 12/8 with tremoring/shaking, ataxia and anorexia ¿ all of unknown duration. The cat was euthermic on presentation. The safety profile of the product was discussed, including that it would have little to no toxicity for mammals since the active ingredient is an Insect Growth Regulator. It was discussed that reactions to the product would not be expected, and the veterinarian was cautioned to rule out other causes (application of other products to the cat, application of products to other animals in the house which could transfer to the cat). Recommendations were made to bathe the cat in non-insecticidal shampoo and lukewarm water for decontamination, and to provide supportive care including: a) Methocarbamol or Diazepam for tremors, b) Phenobarbital or Diazepam for seizures, c) maintaining hydration, and d) monitoring for secondary hyperthermia. Recovery would be anticipated within 24-72 hours. A follow-up call on 12/10/10 revealed that the cat had been treated with Diazepam (valium), phenobarbital, and methocarbamol. She had recovered very well and had been discharged on 12/10/10. The cat was sent home on both phenobarbital and methocarbamol.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

The cat's owners also have dogs, and applied an unknown brand of flea and tick topical drops to the dogs on 12/7/10 as well.