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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-4154

2. Registrant Information.

Registrant Reference Number: PROSAR Case - 1-16543103

Registrant Name (Full Legal Name no abbreviations): The Hartz Mountain Company

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.

19-AUG-08

5. Location of incident.

Country: UNITED STATES

Prov / State: WYOMING

6. Date incident was first observed.

18-AUG-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. 2596-153

Product Name: UltraGuard Rid Flea and Tick Shampoo with Oatmeal for Dogs

  • Active Ingredient(s)
    • D-PHENOTHRIN
      • Guarantee/concentration .27 %

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 applied the product, indicated for use for dogs 6 months and older, to her 9-week old puppy on 8/17/2008.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Mixed breed

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.17

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Lethargy
    • Symptom - Death
    • Symptom - Parvovirus infection
    • Specify - Parvo virus

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

1-16543103: This reporter called on 08/19/2008 to report the exposure of a 9-week old puppy to a flea and tick shampoo containing the active ingredient Phenothrin on 08/17/2008. The caller noticed after using the product that it is intended to be used in dogs over 6 months of age. At the time of the call, the reporter said that her puppy had not been eating much since 08/18/2008 and was lethargic. The caller was advised that the product has a wide margin of safety when used as intended and was informed of the symptoms of overexposure including vomiting, lethargy, muscle tremors and muscle weakness. A recommendation was made to bathe the puppy in a non-medicated shampoo and provide water with Gatorade or Powerade to maintain hydration. A recommendation was made to take the puppy to a DVM for evaluation if the signs did not improve within a few hours. On follow-up on 08/22/2008, the reporter stated that the puppy continued to decline and was seen by a DVM on 08/21/2008 where it tested positive for parvo virus and died. 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