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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2007-7740

2. Registrant Information.

Registrant Reference Number: PROSAR Case 1-15065130

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.

02-JUL-07

5. Location of incident.

Country: UNITED STATES

Prov / State: MISSOURI

6. Date incident was first observed.

01-JUL-07

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.

Product Name: Advanced Care 3 in 1 Foaming Shampoo for Dogs + Puppies - EPA 2596-149

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration .1 %
    • D-CIS, TRANS ALLETHRIN
      • Guarantee/concentration .109 %
    • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
      • Guarantee/concentration .151 %

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).

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

Bulldog

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

70

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>15 min <=2 hrs / >15 min <=2 h

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • General
    • Symptom - Death
  • Nervous and Muscular Systems
    • Symptom - Shaking
  • Respiratory System
    • Symptom - Shortness of breath

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

Information per (name) - Caller initially disconnected prior to transfer Caller had called on behalf of aunt. Shampoo applied to a little dog yesterday. Within 30 minutes, dog expired. Thought dog had a stroke. Went to eat supper, and then it was dead. Shampoo? Animal is buried. Call Back to owner: Owner obtained animal when it was about 3 years old. Medical history before that is unknown. Within last year had "strokes". This is described as "head would shake; couldn't walk right". These had never been medically evaluated. We reviewed information shared by Hartz rep - caller confirms. This was the first time they ever tried this particular product. Normally, Frontline between the shoulders had been used. The infestation was pretty bad this time, so they thought they'd try this product before trying Frontline. During/after product application, dog was breathing heavily in tub; the owner carried animal over to her side of house (apparently niece and aunt live in adjacent apartments), set down; animal started to shake, with foot shaking back and forth (this aspect was not a part of seizure-like activity historically), aunt had a bite to eat at nieces, and went back to find dog had expired. Caller also mentions that aunt had noted a tingling sensation when accidentally getting some on her skin before/during application. Assessment: Difficult breathing and sudden death are not expected effects of the product. Under certain circumstances, the active ingredient can be associated with neurological effects such as tremor. These effects would typically only lead to death if severe and if left untreated - they would not be expected to lead to sudden death. Product can cause a tingling sensation on skin. This is not a sign of poisoning or abnormal product quality.


To be determined by Registrant

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

Death

19. Provide supplemental information here