Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-4007

2. Registrant Information.

Registrant Reference Number: Prosar 1-19655211

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-AUG-09

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

27-AUG-09

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)

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PMRA Registration No. 25922      PMRA Submission No.       EPA Registration No.

Product Name: UltraGuard Flea/TIck Drops for Dogs/Puppies Over 30 lbs (Canada)

• Active Ingredient(s)
  • PERMETHRIN

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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 product was applied to a cat on 08/26/2009. NOTE: This product is not labeled for use on cats.

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

Ragdoll

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

2

7. Weight (provide a range if necessary )

6

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Muscle tremors
  • Symptom - Seizure
  • Symptom - Other
  • Specify - Mental Dullness
  • Symptom - Muscle spasm
  • Specify - Involuntary stretching of legs
  • Symptom - Muscle twitching
  • Specify - Twitching

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?

15

Day(s) / Jour(s)

15. Outcome of the incident

Not recovered / Non 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

1-19655211: A reporter (veterinarian) called on 08/27/2009 to report the exposure of a cat to a canine flea and tick product containing the active ingredient Permethrin. According to the reporter, the product was mistakenly applied to the cat on 08/26/2009. The cat presented to the reporter on 08/27/2009 with tremors and seizures. At the time of the report, the cat had been treated with Valium, atropine and IV fluids. The reporter was in the process of getting injectable methocarbamol for treatment. It was unknown whether the cat had been bathed. The reporter was advised that the cat should be bathed in a non-insecticidal shampoo for decontamination. The tremors should be treated with methocarbamol or diphenhydramine, and the seizures should be treated with Valium or Phenobarbital. Doses were discussed. On follow up on 08/28/2009, a veterinary clinic employee stated that the cat had been on general anesthesia after presentation, but that it had been discontinued. The cat was currently on IV fluids, Valium and methocarbamol. The cat was still having some seizures, but she was more responsive and having voluntary movements. The staff member was advised that sometimes refractory seizures need to be addressed with Propofol or other general anesthetics. Constant rate infusions (CRI) of Valium or Phenobarbital can also be considered. A recommendation was made to monitor the cat for 48-72 hours as signs can re-develop in under-treated cats. On follow up on 08/31/2009, the initial reporter stated that the cat had been on a Valium CRI for 5 days. When the reporter tried to discontinue the CRI, the cat started twitching when touched. The reporter stated that the methocarbamol dose had been decreased, and that the cat was mentally dull. The reporter was advised that the mental dullness may be an effect of the Valium CRI, and to try and reduce the CRI if the cat's seizures were controlled. A recommendation was made to consider increasing the methocarbamol again to address the tremors. Generally the prognosis is good with appropriate care and as long as the animal was not allowed to seizure for very long prior to getting veterinary care. On follow up on 09/02/2009, a veterinary clinic employee stated that the cat was still receiving IV fluids and methocarbamol. The tremors and seizures had resolved, but she had some involuntary stretching of her legs. On follow up on 09/04/2009, the veterinary clinic employee reported that the cat was only on IV fluids, was eating on her own, but was very mentally dull. On follow up on 09/10/2009, the veterinarian reported that the cat was still on methocarbamol, recumbent, but eating and responding to movement and sounds. The cat had improved much more in the past 24 hours than in the previous 2 weeks. The reporter was advised that the duration of signs is highly unusual, as signs generally resolve within 72 hours. A recommendation was made to consider a lipid infusion. The protocol was discussed. No further information was obtained. NOTE: This product is not labeled for use on cats.

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To be determined by Registrant

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

Moderate

19. Provide supplemental information here