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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-6647

2. Registrant Information.

Registrant Reference Number: 170136366

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.

08-AUG-17

5. Location of incident.

Country: UNITED STATES

Prov / State: GEORGIA

6. Date incident was first observed.

06-AUG-17

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 And Kittens Under 5 Lb

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

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2724-813-89459

Product Name: Bio Spot Active Care Flea And Tick Spot On 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.

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).

Between August 1, 2017 and August 3, 2017 the owner applied 0.034 fluid ounces (fl oz) of the Bio Spot under 5 lbs to the 15.0 year old female cat to treat a condition. Between August 1, 2017 and August 3, 2017 the owner applied 1.8 milliliters (mL) of the Bio Spot 5 lbs and over to the 2.0 year old female cat to treat a condition.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Russian Blue

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

15.0

7. Weight (provide a range if necessary )

4.5

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

  • General
    • Symptom - Death

12. How long did the symptoms last?

Unknown / Inconnu

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

On August 6, 2017, the owner found the cat deceased outside. On August 8, 2017 the owner contacted the Animal Product Safety Service (APSS), whose veterinarian stated that etofenprox is in the pyrethroid family, and is safe to use on cats as a topical agent to treat fleas. The APSS veterinarian also stated that it does not result in tremors or seizure activity that can be seen from other pyrethroids, since it is structurally different. The APSS veterinarian stated that s-methoprene is an insect growth regulator (IGR).


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 considered to have a doubtful likelihood of causing the clinical situation. On August 10, 2017 the owner called back regarding a necropsy but the cat had already been buried.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Longhair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

2.0

7. Weight (provide a range if necessary )

8.0

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

  • General
    • Symptom - Death

12. How long did the symptoms last?

Unknown / Inconnu

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

On August 8, 2017 the owner found the cat deceased outside. Later in the afternoon, the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated that etofenprox is in the pyrethroid family, and is safe to use on cats as a topical agent to treat fleas. The APSS veterinarian also stated that it does not result in tremors or seizure activity that can be seen from other pyrethroids, since it is structurally different. The APSS veterinarian stated that s-methoprene is an insect growth regulator (IGR).


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 considered to have a doubtful likelihood of causing the clinical situation. On August 10, 2017 the owner called back regarding a necropsy. At the time of this report, a necropsy is still pending.