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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2007-8861

2. Registrant Information.

Registrant Reference Number: 070069121

Registrant Name (Full Legal Name no abbreviations): Wellmark International

Address: 100 Stone Road West, Suite 111

City: Guelph

Prov / State: ON

Country: Canada

Postal Code: N1G 5L3

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

05-JUL-07

5. Location of incident.

Country: UNITED STATES

Prov / State: ILLINOIS

6. Date incident was first observed.

04-JUL-07

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. 2724404270

Product Name: Bio Spot Flea and Tick Spray for Cats and Kittens2724404270

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration .27 %
    • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
      • Guarantee/concentration .62 %
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration .37 %
    • PYRETHRINS
      • Guarantee/concentration .2 %

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).

On July 1 and 2, 2007 at approximately 12:00 p.m. CDT, the owner applied the product to her elderly two domestic short hair cats-- an 18 year old, neutered male and an approximately 15 year old, sex unknown. The product was applied dermally to treat fleas and ticks, and the use was inappropriate duration, as it was not necessary to apply it twice.

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 Short Hair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

18

7. Weight (provide a range if necessary )

7.3

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

>3 days <=1 wk / >3 jours <=1 sem

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Weight loss
  • General
    • Symptom - Pale mucous membrane colour
    • Symptom - Hypothermia
  • Cardiovascular System
    • Symptom - Heart murmur
  • Gastrointestinal System
    • Symptom - Constipation
  • Eye
    • Symptom - Discharge eye
    • Specify - mucoid discharge
  • Nervous and Muscular Systems
    • Symptom - Recumbent
    • Specify - lateral recumbency
    • Symptom - Coma
  • General
    • Symptom - Parasitism
    • Specify - parasitism
  • Cardiovascular System
    • Symptom - Shock
  • Blood
    • Symptom - Anemia
  • General
    • Symptom - Death

12. How long did the symptoms last?

>2 hrs <=8 hrs / > 2 h < = 8 h

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

The emergency veterinarian performed a physical examination on patient one, provided fluids, gave a 1.5 mg pepcid injection intravenously, a 30 ml warm soapy water enema, and a 0.65 mg cefazolin injection intravenously. The owner declined blood work, urinalysis, radiographs, blood transfusion, and hospitalization. Cat passed away on July 5, 2007 Necropsy results: Fax from attending veterinary office states that animal has had a history of urinary problems. Heart murmur is a grade 1 systolic murmur. Necropsy results show pyelonephritis (embolosuppurative to pyogranulomatous) and hepatic necrosis (pyogranulomatous multifocal). The hair toxicology screen was positive for methoprene, pyrethroids and piperonyl butoxide. The liver, fat and kidney were positive for phenothrin. The kidney and fat were positive for piperonyl butoxide.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Product not used according to label directions. Product used inappropriately in duration - applied twice in one day. Label states to check with your veterinarian before applying on elderly animals. The Animal Product Safety Service (APSS) staff suggested that although the product was applied inappropriately in duration, the expected signs from this exposure would not be more than mild irritation. Severe signs were not expected as a result of this application. APSS determined the product was considered to have doubtful likelihood of causing the clinical situation. Necropsy indicated presence of Phenothrin, an active ingredient not contained in this product. This would indicate cat exposed to another pesticde product.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Short Hair

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

15

7. Weight (provide a range if necessary )

Unknown

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

>3 days <=1 wk / >3 jours <=1 sem

11. List all symptoms

System

  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

No

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

Cat died on July 4, 2007. Necropsy Results: Necropsy results show pyelonephritis (embolosuppurative to pyogranulomatous) and hepatic necrosis (pyogranulomatous multifocal). The hair toxicology screen was positive for methoprene, pyrethroids and piperonyl butoxide. The liver and fat were positive for phenothrin and piperonyl butoxide.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Product not used according to label directions. Product used inappropriately in duration - applied twice in one day. Label states to check with your veterinarian before applying on elderly animals. The Animal Product Safety Service (APSS) staff suggested that although the product was applied inappropriately in duration, the expected signs from this exposure would not be more than mild irritation. Severe signs were not expected as a result of this application. APSS determined the product was considered to have doubtful likelihood of causing the clinical situation. Necropsy indicated presence of Phenothrin, an active ingredient not contained in this product. This would indicate cat exposed to another pesticide product.