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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-5258

2. Registrant Information.

Registrant Reference Number: Prosar 1-20494710

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.

22-OCT-09

5. Location of incident.

Country: UNITED STATES

Prov / State: OHIO

6. Date incident was first observed.

22-OCT-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. 2596-151

Product Name: UltraGuard Flea/Tick Drops for Dogs/Puppies 4-15 lbs

  • Active Ingredient(s)
    • D-PHENOTHRIN
      • Guarantee/concentration 85.7 %

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 product was applied to the dog on 10/20/2009.

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Pug

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

3

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

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Seizure
    • Symptom - Shaking
  • Respiratory System
    • Symptom - Respiratory failure
  • 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?

1

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

1-20494710: A reporter (veterinarian) called on 10/22/2009 to report the exposure of a dog to a flea and tick product containing the active ingredient Phenothrin. According to the reporter, the product was applied to the dog on 10/20/2009. One hour prior to the report, the dog had a seizure. The reporter stated that the dog is very thin and does not appear healthy. The reporter was advised that the product has a wide margin of safety when used according to label directions. An overexposure to pyrethrins typically results in signs within 30 minutes to 3 hours, but may be delayed up to 24 hours. Onset of signs would not be expected days after product exposure. The signs of pyrethrin toxicity were discussed. A recommendation was made to decontaminate the dog with a non-insecticidal shampoo and treat symptomatically. A recommendation was also made to monitor the dog's body temperature, maintain hydration, and treat seizures with phenobarbital. On follow up on 10/23/2009, the reporter stated that the dog was treated with Valium and phenobarbital which controlled the seizures for about 8 hours. General anesthesia was induced when seizures recurred. The morning of the report, the dog was shaking some and given oral phenobarbital. Prior to the follow up, the dog went into respiratory failure and died. The company's necropsy program was discussed. 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