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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-3646

2. Registrant Information.

Registrant Reference Number: Prosar case 1-16111771

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.

06-MAY-08

5. Location of incident.

Country: UNITED STATES

Prov / State: MICHIGAN

6. Date incident was first observed.

06-MAY-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 Plus for Dogs and Puppies 4-15 lbs

  • 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 reporter applied the product to the pet on 5/6/08.

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

Border Collie

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.33

7. Weight (provide a range if necessary )

17

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

  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Diarrhea
  • 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?

Unknown

14. b) How long was the animal hospitalized?

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

1-16111771: The reporter called on 5/6/08 to report she had applied a topical flea and tick product containing the active ingredients Phenothrin and Methoprene to her 4 month old puppy about 6 hours previously. The reporter had then left the home and returned later to find the puppy had vomited and had diarrhea. The safety profile of the product was discussed, including the fact that GI symptoms would not be expected from dermal exposure. A recommendation was made to bathe the puppy with a non-medicated shampoo or hand dish soap, and to take it to a veterinarian if the symptoms persisted after the bath. Several follow-up calls were placed. The reporter called back on 5/12/08 to reveal the puppy had been treated by a veterinarian but had passed away the next morning. Company sponsored necropsy was discussed.


To be determined by Registrant

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

Death

19. Provide supplemental information here