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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-4183

2. Registrant Information.

Registrant Reference Number: Prosar case 1-16407075

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.

16-JUL-08

5. Location of incident.

Country: UNITED STATES

Prov / State: KANSAS

6. Date incident was first observed.

Unknown

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. 2596-151

Product Name: UltraGuard Flea and Tick Drops for Dogs and Puppies 31-60 lbs

  • Active Ingredient(s)
    • 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 1 hour before the reporter took the puppy in to the veterinarian for an ear cropping procedure. The puppy weighed 19 lbs. and a product dose for a dog 31-60 lbs. was applied. Per the reporter, he knew the dog was underweight for the product so he had used less of it on the dog thinking it would be OK.

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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Boxer

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.24

7. Weight (provide a range if necessary )

19

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

  • 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?

No

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

1-16407075: The reporter called on 7/16/08 to report the death of his 13 week old Boxer puppy after application of a topical flea and tick product containing the active ingredient Phenothrin. According to the reporter, he had applied the product 1 hour before he had taken the puppy in to the veterinarian for an ear cropping procedure. The puppy had passed away on the operating table while under general anesthesia. The reporter wondered if the product had contributed to the puppy's death. It was discussed that some Boxers can be sensitive to anesthetics, and this sensitivity can cause severe reactions. It was also discussed that it was more likely that the puppy had had a reaction to an anesthetic agent than a reaction to the product. A recommendation was made to further discuss the cause of death with the attending veterinarian. Note: The puppy weighed 19 lbs. and a product dose for a dog 31-60 lbs. was applied. Per the reporter, he knew the dog was underweight for the product so he had used less of it on the dog thinking it would be OK.


To be determined by Registrant

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

Death

19. Provide supplemental information here