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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-2203

2. Registrant Information.

Registrant Reference Number: 110036041

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

Address: 100 Stone Road West, Suite 111

City: Guelph

Prov / State: Ontario

Country: Canada

Postal Code: N1G5L3

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

Domestic Animal

4. Date registrant was first informed of the incident.

27-MAR-11

5. Location of incident.

Country: UNITED STATES

Prov / State: IDAHO

6. Date incident was first observed.

27-MAR-11

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. 2724-504-270

Product Name: Bio Spot Spot On Flea and Tick Control For Cats 5 lbs and Over

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration 3.6 %
    • ETOFENPROX
      • Guarantee/concentration 40 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

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).

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

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

2

5. Sex

Unknown

6. Age (provide a range if necessary )

0.055

7. Weight (provide a range if necessary )

0.5

lbs

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

Unknown / Inconnu

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?

Contact treat.area/Contact surf. traitée

specify Relay exposure through mother

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

On March 27, 2011, the owner applied the product to the heavily flea infested stray (kittens' mother). Several hours later, the owners woke to find the kitten's two litter mates had died, so they contacted the Animal Product Safety Service (APSS) shortly after. The APSS veterinarian stated death was not expected in the kittens. The APSS technician recommended that the owner take the kitten to the veterinarian, have the veterinarian call for information, provide flea treatment, use a flea comb, and provide symptomatic and supportive care. The owner took the kitten to the veterinarian, who contacted the APSS to update the case. The regular veterinarian stated that the kitten was anemic, and no other cares were implemented.


To be determined by Registrant

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

Death

19. Provide supplemental information here

The APSS veterinarian stated that the substance was not considered to be related to causing the clinical situation.

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

Unknown

6. Age (provide a range if necessary )

0.055

7. Weight (provide a range if necessary )

0.5

lbs

8. Route(s) of exposure

Unknown

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

  • Blood
    • Symptom - Anemia
  • 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?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Died

16. How was the animal exposed?

Contact treat.area/Contact surf. traitée

specify Relay exposure through mother

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

On March 27, 2011, the owner applied the product to the heavily flea infested stray (kittens' mother). Several hours later, the owners woke to find the kitten's two littermates had died, so they contacted the Animal Product Safety Service (APSS) shortly after. The APSS veterinarian stated death was not expected in the kittens. The APSS technician recommended that the owner take the kitten to the veterinarian, have the veterinarian call for information, provide flea treatment, use a flea comb, and provide symptomatic and supportive care. The owner took the kitten to the veterinarian, who contacted the APSS to update the case. The regular veterinarian stated that the kitten was anemic, and no other cares were implemented.


To be determined by Registrant

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

Death

19. Provide supplemental information here

The APSS veterinarian stated that the substance was not considered to be related to causing the clinical situation. On March 30, 2011 an APSS assistant contacted the owner to update the case. The owner stated that the kitten had died on March 29, 2011. A necropsy was rejected by the owner.