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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-4180

2. Registrant Information.

Registrant Reference Number: Prosar case 1-16402903

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.

15-JUL-08

5. Location of incident.

Country: UNITED STATES

Prov / State: VIRGINIA

6. Date incident was first observed.

12-JUL-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. 2596-125

Product Name: UltraGuard Flea and Tick Spray for Dogs 16 fl oz

  • Active Ingredient(s)
    • TETRACHLORVINPHOS
      • Guarantee/concentration 1.08 %

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 approximately 1 week prior to the call.

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

Other

2. Type of animal affected

Dog / Chien

3. Breed

Pomeranian

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

4.5

7. Weight (provide a range if necessary )

12.5

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Anorexia
    • Symptom - Diarrhea
  • General
    • Symptom - Lethargy
  • Respiratory System
    • Symptom - Dyspnea
  • Eye
    • Symptom - Tearing
  • Gastrointestinal System
    • Symptom - Salivating excessively
  • Eye
    • Symptom - Miosis
  • Renal System
    • Symptom - Other
    • Specify - Micturition
  • Nervous and Muscular Systems
    • Symptom - Muscle tremors
    • Symptom - Muscle weakness
    • Symptom - Agitation
    • Symptom - Ataxia
    • Symptom - Paralysis
    • Symptom - Coma
  • 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?

Unknown

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

1-16402903: The reporter called on 7/15/08 to report the illness of her parent¿s female dog after the application of a topical flea and tick product containing the active ingredient Tetrachlorvinphos (organophosphate). According to the reporter, the product had been applied about 1 week prior to the call. On 7/12, the dog had developed lethargy, anorexia, and diarrhea. She had been taken to a veterinarian on 7/14, where blood had been drawn and the dog has been discharged. As of the time of the call, the dog had been taken back to the veterinarian based on the results of the lab work. Atropine treatment had been started but per the reporter, the dog had developed dyspnea, lacrimation, salivation, miosis, micturition, muscle tremors, muscle weakness, ataxia, agitation, paralysis, and had slipped into a coma. The active ingredient was discussed with the reporter, as was a cholinesterase test. A recommendation was made regarding treatment for organophosphate exposure (Atropine and 2-PAM). A follow-up call on 7/17 revealed that the dog had passed away the evening of 7/15. The reporter stated that a cholinesterase test had been done and that the attending veterinarian would be calling when he had received the results. The attending veterinarian called on 7/25/08 to report the results of the cholinesterase testing. According to the veterinarian, the dog had presented on 7/14 for vomiting. By the next day, she had developed miosis, salivation, lacrimation, and diarrhea. Aggressive therapy had been initiated with IV fluids and atropine every few hours to try and reverse a presumed organophosphate toxicity. The dog had passed away about 9 p.m. on 7/15. The cholinesterase test had come back low at 827 (normal 1271-5101).


To be determined by Registrant

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

Death

19. Provide supplemental information here