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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2007-7766

2. Registrant Information.

Registrant Reference Number: PROSAR Case 1-15299758

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.

09-SEP-07

5. Location of incident.

Country: UNITED STATES

Prov / State: OHIO

6. Date incident was first observed.

09-OCT-07

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.

Product Name: Advanced Care Ear Mite Treatment for Cats - 68688-41-2596

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

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

Product Name: UltraGuard Plus Drops for Cats 5 lbs and Over - 2724-504-2596

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration 3.6 %
    • ETOFENPROX
      • Guarantee/concentration 40 %

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).

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

Domestic Longhair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

6.5

7. Weight (provide a range if necessary )

9

lbs

8. Route(s) of exposure

Skin

Unknown

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

  • General
    • Symptom - Death
  • Eye
    • Symptom - Pupil dilation
  • Gastrointestinal System
    • Symptom - Salivating excessively
  • Respiratory System
    • Symptom - Difficulty Breathing

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

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

History: Caller just used the ear mite treatment for the first time today. States that they have a system and she has done the same thing every month for 7 years. She bathes the cat in water and a small amount of the Natures Goodness oil. After the bath she applied the flea and tick drops. This has never been a problem in the past. Today she applied the ear mite drops and the cat went and ran under the couch. She went to get him and he was foaming at the mouth, his eyes were dilating and he was breathing really hard. She knew he was sick and had been poisoned. She immediately put him in the bathtub with just tap water to remove the products. The symptoms persisted and she brought him into the Veterinarian. Veterinarian stated that the ingredients in the ear mite treatment should never be used on cats, it is poisonous to cats. They have given him another bath, cleaned out his ears, and given him something to absorb the products in his system. Veterinarian staff informed her that he has a 50/50 chance of survival. At the Veterinarian they specifically asked about the ear mite treatment and said that the symptoms were related to the ear mite treatment ingredients. Assessment: - The product has a wide margin of safety when used according to label instructions and is not expected to cause the symptoms described - Sometimes after application of a topical flea and tick product cats can self-groom and the ingestion of the product causes a bad taste and drooling/foaming at the mouth - The AI in the ear mite treatment can be harmful for cats in much higher doses or percentages. At .05% the AI would not be expected to cause toxicity for the cat. - Symptoms of pyrethrin toxicity are typically vomiting, muscle tremors or fasiculations and seizing - The treatment that has been performed at this time should have removed all of the products AI's from the cat¿s fur - There is no antidote for the product AI, treatment will be symptomatic and supportive - Callback or have Veterinarian callback with additional questions/concerns 09/12/07 Attempted follow-Up contact Left message, and my name and number, asking for a f/u CB. I explained that I understood that Hooday had passed away. , I again sympathized with them and offered to speak with them at their earliest convenience, leaving my name and the direct line to my desk.


To be determined by Registrant

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

Death

19. Provide supplemental information here