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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-4160

2. Registrant Information.

Registrant Reference Number: PROSAR Case - 1-16543126

Registrant Name (Full Legal Name no abbreviations): The Hartz Mountain Group

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.

19-AUG-08

5. Location of incident.

Country: UNITED STATES

Prov / State: INDIANA

6. Date incident was first observed.

16-AUG-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. 2596-150

Product Name: UltraGuard Plus Flea and Tick Drops for Dogs and Puppies

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration 2.3 %
    • D-PHENOTHRIN
      • Guarantee/concentration 85.7 %

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 product was applied to the dog's back on 8/16/2008

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

Dog / Chien

3. Breed

Chihuahua

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

1

7. Weight (provide a range if necessary )

5

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Shakiness
    • Symptom - Seizure
  • General
    • Symptom - Death

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?

Yes

14. b) How long was the animal hospitalized?

2

Day(s) / Jour(s)

15. Outcome of the incident

Died

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

1-16543126: The reporter called on 08/19/2008 to report the exposure of a 1-year old Chihuahua to a topical flea and tick product containing the active ingredients Methoprene and Phenothrin on 08/16/2008. According to the reporter, the product was applied to the dog¿s back and there may have been ingestion of some of the product. The dog developed muscle tremors within 2 hours of product application, and she had a seizure sometime during that night and was seen by her veterinarian. The dog was treated by the DVM with phenobarbital and activated charcoal. The dog died 08/18/2008 and the caller reported that the DVM said the dog¿s death was due to toxicosis from the product. A necropsy was being conducted at (name) University at the time of the call. No further information was obtained


To be determined by Registrant

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

Death

19. Provide supplemental information here