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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2007-7776

2. Registrant Information.

Registrant Reference Number: PROSAR Case 1-15347535

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.

24-SEP-07

5. Location of incident.

Country: UNITED STATES

Prov / State: OHIO

6. Date incident was first observed.

21-SEP-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. EPA 2596-124

Product Name: Control Flea + Tick Conditioning Shampoo for Dogs - EPA 2596-124

  • Active Ingredient(s)
    • D-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

Jack Russell Terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

2

7. Weight (provide a range if necessary )

Unknown

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 - Death
    • Symptom - Lethargy
  • Respiratory System
    • Symptom - Difficulty Breathing
  • Gastrointestinal System
    • Symptom - Dry mouth
    • Symptom - Rectal hemorrhage
    • Symptom - Bloody diarrhea
  • Skin
    • Symptom - Pale mucous membrane colour
  • Respiratory System
    • Symptom - Rapid breathing

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?

Unknown

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

History: Caller bathed her 2 yo, female, Jack Russell Terrier with Control Conditioning Flea and Tick Shampoo for the first time 3 days ago. Within several hours after bathing, the dog became lethargic. Later in the middle of the night, the dog developed "rapid and hard" breathing through her nose, and bloody diarrhea. Owner called her emergency clinic. Veterinary staff recommended she bathe the dog with dish soap. Following bathing with dish soap at home, the dog was taken promptly to the E-clinic, where vet staff bathed the dog a second time. The dog presented with pale MM's. The veterinarian prescribed unknown "pills" for the diarrhea. Owner then discussed with her veterinarian, the "new" shampoo that she used. Caller states that her veterinarian was confident that the Hartz shampoo was responsible for the symptoms that were occurring, as they had "seen this same reaction before in other animals". The veterinarian did not perform any diagnostic tests or bloodwork. The dog was sent home, however, dog owner could not administer the antidiarrheal medication, as the dog had developed a very dry mouth. Yesterday, the dog died suddenly at home and was buried. Owner declines necropsy testing, as the dog has already been buried and caller agrees with her veterinarian, that the product killed her dog. Assessment: - Discussed with caller that the symptoms described are atypical following a dermal exposure and are not related to product use. - Talked about the wide safety margin and low toxic order of the active ingredient, d-trans Allethrin < 1%, and that healthy, adult dogs are not expected to be sensitive with normal, routine use. - Empathized with caller over their loss and situation. Given the history provided, I am uncertain as to what may have caused your dog's symptoms and death at this time. Hartz products have a very wide margin of safety and low level of toxicity when used according to the labeled directions.


To be determined by Registrant

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

Death

19. Provide supplemental information here