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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-2691

2. Registrant Information.

Registrant Reference Number: Prosar 1-18466583

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-MAY-09

5. Location of incident.

Country: UNITED STATES

Prov / State: IOWA

6. Date incident was first observed.

11-MAY-09

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. 2596-139

Product Name: UltraGuard Plus Flea/Tick Collar for Puppies White

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration 1.02 %
    • TETRACHLORVINPHOS
      • Guarantee/concentration 14.55 %

7. b) Type of formulation.

Other (specify)

collar

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 collar was applied to the puppy on 05/11/2009.

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

Pomeranian

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 )

3.8

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>2 hrs <=8 hrs / >2 h <=8 h

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Vomiting
  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Abnormal feces colour
    • Symptom - Diarrhea
  • Skin
    • Symptom - Jaundice
  • General
    • Symptom - Other
    • Specify - Multiple organ failure
  • Blood
    • Symptom - Blood urea nitrogen increased
    • Specify - very elevated BUN
  • Liver
    • Symptom - Elevated liver enzymes
  • 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

1-18466583: A reporter (dog owner) called on 05/14/2009 to report the exposure of her puppy to a flea and tick collar containing the active ingredients Tetrachlorvinphos and Methoprene. According to the reporter, the collar was placed on the puppy on 05/11/2009. Within 2-3 hours following collar placement, the puppy began vomiting. The collar was removed at that time, but the vomiting continued on 05/12/2009. The puppy was taken to the veterinarian on 05/12/2009 where it was given fluids and an unknown medication to settle the stomach. The puppy was taken home that same day and became very lethargic. The dog was taken back to the veterinary clinic that evening where it was bathed and given more fluids. On 05/13/2009, the puppy had yellow-colored bowel movements that then became diarrhea. The puppy was seen again by the veterinarian where it was hospitalized and given more fluids. The puppy was jaundiced and had persistent vomiting on 05/14/2009. Blood work was collected and was pending at the time of the report. The reporter provided the veterinarian's telephone number for follow up. The reporter was advised that the signs described are not expected with routine product use. An initial attempt at follow up with the veterinarian on 05/15/2009 was unsuccessful. On 05/18/2009, contact was established with the attending veterinarian. According to the veterinarian, the puppy's blood work indicated multiple organ failure (BUN greater than 300, liver enzymes in the 3000-4000 range). While the veterinarian did not think that the puppy's signs were consistent with organophosphate toxicity secondary to collar placement, several doses of atropine were given. The puppy's owner was encouraged to touch base with the breeder given the dog's sudden and severe illness. The puppy was taken home on 05/16/2009. It died at home over the weekend. The veterinarian was advised that the brief exposure to the collar would be unlikely to result in the signs described. The veterinarian was encouraged to consider a congenital reason for the illness. There was a discussion regarding cholinesterase testing and necropsy to determine cause of death, but it may be too late depending on the time of the puppy's death. 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