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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-0862

2. Registrant Information.

Registrant Reference Number: Prosar 1-21304927

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.

13-JAN-10

5. Location of incident.

Country: UNITED STATES

Prov / State: VIRGINIA

6. Date incident was first observed.

22-JAN-10

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 (non-specific)

  • 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 2 dogs on 01/10/2010.

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

Miniature Schnauzer

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

6

7. Weight (provide a range if necessary )

16

lbs

8. Route(s) of exposure

Skin

Unknown

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Anorexia
  • General
    • Symptom - Adipsia
  • Renal System
    • Symptom - Low urine output
  • Gastrointestinal System
    • Symptom - Constipation
    • Specify - "No bowel movement"
  • General
    • Symptom - Pain
    • Symptom - Other
    • Specify - "Something abnormal around privates"
    • Symptom - Hypothermia
  • Gastrointestinal System
    • Symptom - Diarrhea
  • Renal System
    • Symptom - Renal 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?

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

1-21304927: A reporter (dog owner) called on 01/13/2010 to report the exposure of her 2 dogs to a flea and tick product containing the active ingredient Phenothrin. According to the reporter, the product was applied to the dogs on 01/10/2010. Within 24 hours, Dog #1 (1st Subform III) developed vomiting, was anorexic and not drinking, had decreased urination and was not defecating. The reporter thought it was possible that Dog #1 had licked product off of the other dog at some point. At the time of the report, Dog #1 had eaten without vomiting and had been given two doses of 81mg aspirin under the direction of a veterinarian. Dog #2 was asymptomatic. The reporter was advised that the signs described are not expected following routine use of the product. Ingestion may result in gastrointestinal signs such as vomiting, but the signs may be indicative of an unrelated issue. A recommendation was made to bathe the dog with Dawn dish soap and have the dog evaluated by a veterinarian. On follow up on 01/15/2010, the reporter stated that Dog #1 was evaluated by a veterinarian on 01/13/2010. The dog "looked like he was in pain" and the reporter elected to treat the dog conservatively with an unknown injection and oral medication. On 01/15/2010, Dog #1 started vomiting again and developed diarrhea. Dog #1 was taken back to the veterinarian where he was found to be hypothermic. The veterinarian also indicated feeling "something abnormal around his privates". Blood work was done and revealed kidney failure. The dog died shortly thereafter and was cremated. Dog #2 remained asymptomatic. The reporter was advised that the product is not known to result in kidney failure. 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