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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-3986

2. Registrant Information.

Registrant Reference Number: Prosar 1-19445474

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.

07-AUG-09

5. Location of incident.

Country: UNITED STATES

Prov / State: INDIANA

6. Date incident was first observed.

06-AUG-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 31-60 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 08/05/2009.

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

Mixed breed

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

7

7. Weight (provide a range if necessary )

55

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Recumbent
  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Hyperthermia
    • 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?

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

1-19445474: A reporter (veterinarian) called on 08/07/2009 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 08/05/2009. By 08/06/2009, the dog was laterally recumbent, lethargic, and anorexic. The owners gave the dog a brief bath, but the reporter could still smell the product on the dog when it presented to him on 08/07/2009. At the time of the report, the dog had been bathed in Dawn hand dish soap and a complete blood count had been run and was determined to be within normal limits. The reporter was advised that adverse events are not expected with labeled use of the product. The reporter was also advised that bathing and symptomatic and supportive care are appropriate measures for suspected sensitivity to the product. On follow up, the reporter stated that the dog died on 08/07/2009. He had become hyperthermic, and the reporter was able to regulate his temperature. The dog's owners were instructed to bring the dog to the emergency clinic for overnight care, but they brought the dog home where he died that night. A recommendation was made to consider necropsy to try and determine the cause of death. 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