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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-2916

2. Registrant Information.

Registrant Reference Number: PROSAR 1-22480099

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.

03-MAY-10

5. Location of incident.

Country: UNITED STATES

Prov / State: MASSACHUSETTS

6. Date incident was first observed.

02-MAY-10

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. 2596-22

Product Name: InControl Flea and Tick Shampoo for Dogs and Puppies Fresh Citrus

  • Active Ingredient(s)
    • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
      • Guarantee/concentration .149 %
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration .089 %
    • PYRETHRINS
      • Guarantee/concentration .045 %

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 owner bathed the 13 year old dog with the product on 5/2/10. The reporter stated that when she had used the same product 3 weeks previously, the dog acted groggy for a few days and was then fine.

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

Yorkshire Terrier (Yorkie)

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

13

7. Weight (provide a range if necessary )

10

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Loss of appetite
    • Specify - depressed appetite
  • General
    • Symptom - Death

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

1-22480099: The reporter called the registrant on 5/3/10 to report the death of her 13 year old female Yorkshire Terrier after the dog had been exposed to flea and tick shampoo containing the active ingredients Pyrethrins, Piperonyl Butoxide and N-Octyl Bicycloheptene Dicarboximide. According to the reporter (animal owner), the dog was bathed on 5/2/10. Later on in the day, the dog seemed to be lethargic (sleeping more) and had a depressed appetite. The reporter inquired about the relationship of the product to the dog┐s symptoms, stating that the dog had acted in a similar manner the previous month after being bathed with the shampoo. During the call the safety profile of the product was discussed. A recommendation was made to bathe the dog again using a non-insecticidal pet shampoo or hand dish washing liquid, and to seek veterinary care if the dog┐s symptoms persisted or worsened. Contact with the reporter was re-established on 5/5/10. The dog died late in the evening on 5/3/10. No additional symptoms developed. The reporter had not been able to take the dog to a veterinarian that evening but had planned to seek veterinary care the following day. The reporter iterated that when she had used the same product 3 weeks previously, the dog acted groggy for a few days and was then fine. The dog was buried.


To be determined by Registrant

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

Death

19. Provide supplemental information here

The reporter stated that when she had used the same product 3 weeks previously, the dog acted groggy for a few days and was then fine.