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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-4186

2. Registrant Information.

Registrant Reference Number: Prosar case 1-16395219

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.

14-JUL-08

5. Location of incident.

Country: UNITED STATES

Prov / State: OKLAHOMA

6. Date incident was first observed.

12-JUL-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. 2596-151

Product Name: UltraGuard Flea Tick Drops for Dogs and Puppies 4-15 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 reporter got the puppy on 7/12/08. According to the person she purchased the puppy from, the puppy was 5 months old, had received his 1st round of vaccinations, and had received a topical flea and tick treatment on 7/1/08.

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

Dachshund

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.42

7. Weight (provide a range if necessary )

3

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 - Diarrhea
    • Symptom - Vomiting
    • Symptom - Anorexia
    • Symptom - Bloody diarrhea
  • General
    • Symptom - Death
    • Symptom - Parvovirus infection
    • Specify - Parvovirus suspected

12. How long did the symptoms last?

Persisted until death

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

No

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

1-16395219: The reporter called on 7/14/08 to report the death of her 5 month old puppy after application of a topical flea and tick product containing the active ingredient Phenothrin. According to the reporter, she had purchased the puppy and taken him home on 7/12/08. Per the people from whom she purchased the puppy, the product (4-15 lbs dog size) had been applied on 7/1/08. Supposedly the puppy also had had 1 round of vaccinations. The reporter stated that the puppy had developed vomiting, anorexia, and diarrhea on 7/12, and the symptoms had continued until the time of the call. In addition, the diarrhea had become bloody. The reporter questioned whether the symptoms would be related to product exposure as she suspected the puppy weighed less than 4 lbs. The safety profile of the product was discussed. A recommendation was made to offer Pedia-lyte mixed with water to keep the puppy hydrated, and to have the puppy evaluated by a veterinarian due to its young age and small size. It was also discussed that if the reporter thought the product had been applied more recently than 7/1, she could try to bathe the puppy in hand dish washing soap to try and remove any remaining product. Symptomatic and supportive care was recommended while other causes of the symptoms were investigated. A follow-up call revealed that the puppy had passed away without being seen by a veterinarian. The reporter suspected Parvovirus.


To be determined by Registrant

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

Death

19. Provide supplemental information here