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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-1580

2. Registrant Information.

Registrant Reference Number: Prosar 1-17922971

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.

26-MAR-09

5. Location of incident.

Country: UNITED STATES

Prov / State: CALIFORNIA

6. Date incident was first observed.

24-MAR-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. 2596-83

Product Name: Non-Specific UltraGuard Flea/Tick Collar for Cats

  • Active Ingredient(s)
    • TETRACHLORVINPHOS
      • Guarantee/concentration 14.55 %

7. b) Type of formulation.

Other (specify)

Collar

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 an 11 year old cat and a 15-16 year old cat two weeks prior to the report (03/12/2009). NOTE: This product is not labeled for use on aged cats (defined as older than 10 years of age).

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

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

11

7. Weight (provide a range if necessary )

11

lbs

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

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

  • Eye
    • Symptom - Blindness (temporary)
    • Specify - "Appeared blind"
  • Nervous and Muscular Systems
    • Symptom - Abnormal gait
    • Specify - "Circling to the right"
    • Symptom - Staggering
    • Specify - "Stumbling while walking"
    • Symptom - Disorientation
    • Specify - "Walking into walls, walking into and over food and water bowls"
  • 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

1-17922971: A reporter called on 03/26/2009 to report the exposure of two cats to a flea and tick collar containing the active ingredient Tetrachlorvinphos. According to the reporter, the product was applied to both cats two weeks prior to the report. The reporter removed the collar from Cat #1 (1st Subform III) 1.5 weeks ago and bathed his neck with soap and water. It is unknown why the reporter removed the collar. Two days prior to the report, the cat seemed to be blind and was circling to the right. The day prior to the report, the cat was stumbling while walking and walking over and into his food and water bowls. The cat was evaluated by a veterinarian on 03/25/2009. The cat was tested for feline leukemia and FIV. A urinalysis and creatinine were performed. It was unknown what was causing the signs. The veterinarian gave the cat subcutaneous fluids and a possible antibiotic injection and sent the cat home with the reporter. The cat¿s signs worsened and he died on 03/26/2009. The reporter removed the collar from Cat #2 (2nd Subform III) on 03/25/2009 and bathed her neck with soap and water. The reporter stated that Cat #2 is not drinking water and is sleeping more. The reporter was advised that the active ingredient in the collar is an organophosphate. The reporter was also advised of common signs seen with an adverse reaction to the active ingredient and that signs typically develop within 24 hours of product exposure. The reporter was advised that there is an antidote available in the event of an adverse reaction. It was also advised that the cat¿s signs are not consistent with an adverse reaction to the active ingredient, and that the treatment provided by the veterinarian is not consistent with the treatment for a suspected organophosphate toxicity. A recommendation was made to have Cat #2 evaluated by a veterinarian. The reporter was informed that a cholinesterase test is available should the veterinarian suspect organophosphate toxicity. Finally, the reporter was advised that the product is not labeled for aged cats. Multiple attempts at follow up were unsuccessful. No further information was obtained. NOTE: The product is not labeled for use on aged cats (designated as cats older than 10 years of age).


To be determined by Registrant

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

Death

19. Provide supplemental information here

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

15.5

7. Weight (provide a range if necessary )

12

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

  • General
    • Symptom - Adipsia
    • Symptom - Sleepiness

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Unknown

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Unknown/Inconnu

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

1-17922971: A reporter called on 03/26/2009 to report the exposure of two cats to a flea and tick collar containing the active ingredient Tetrachlorvinphos. According to the reporter, the product was applied to both cats two weeks prior to the report. The reporter removed the collar from Cat #1 (1st Subform III) 1.5 weeks ago and bathed his neck with soap and water. It is unknown why the reporter removed the collar. Two days prior to the report, the cat seemed to be blind and was circling to the right. The day prior to the report, the cat was stumbling while walking and walking over and into his food and water bowls. The cat was evaluated by a veterinarian on 03/25/2009. The cat was tested for feline leukemia and FIV. A urinalysis and creatinine were performed. It was unknown what was causing the signs. The veterinarian gave the cat subcutaneous fluids and a possible antibiotic injection and sent the cat home with the reporter. The cat¿s signs worsened and he died on 03/26/2009. The reporter removed the collar from Cat #2 (2nd Subform III) on 03/25/2009 and bathed her neck with soap and water. The reporter stated that Cat #2 is not drinking water and is sleeping more. The reporter was advised that the active ingredient in the collar is an organophosphate. The reporter was also advised of common signs seen with an adverse reaction to the active ingredient and that signs typically develop within 24 hours of product exposure. The reporter was advised that there is an antidote available in the event of an adverse reaction. It was also advised that the cat¿s signs are not consistent with an adverse reaction to the active ingredient, and that the treatment provided by the veterinarian is not consistent with the treatment for a suspected organophosphate toxicity. A recommendation was made to have Cat #2 evaluated by a veterinarian. The reporter was informed that a cholinesterase test is available should the veterinarian suspect organophosphate toxicity. Finally, the reporter was advised that the product is not labeled for aged cats. Multiple attempts at follow up were unsuccessful. No further information was obtained. NOTE: The product is not labeled for use on aged cats (designated as cats older than 10 years of age).


To be determined by Registrant

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

Minor

19. Provide supplemental information here