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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-4505

2. Registrant Information.

Registrant Reference Number: 190120115

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.

10-JUL-19

5. Location of incident.

Country: UNITED STATES

Prov / State: MARYLAND

6. Date incident was first observed.

30-JUN-19

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. 2724-813-89459

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.

1.8

Units: mL

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 June 2, 2019, the owner applied 1.8 milliliters (mL) of the product to both cats to treat a condition. The owner waited only two weeks to see if the flea burden improved. There was no improvement so the owner applied 1.8 mL of the product to both cats again on June 16, 2019. This is a monthly treatment.

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 Longhair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

2.5

7. Weight (provide a range if necessary )

10.0

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 - Lethargy
    • Symptom - Abnormal behaviour
    • Specify - Behavior Change
  • Gastrointestinal System
    • Symptom - Loss of appetite
  • General
    • Symptom - Adipsia
    • 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

On June 30, 2019, the cat developed symptoms. On July 2, 2019, the cat passed away. On July 10, 2019, the owner contacted the Animal Product Safety Service (APSS) whose veterinarian stated that etofenprox is an ether pyrethroid and that the median lethal dose (LD 50) is over 40,000 milligrams per kilogram (mg/kg). The APSS veterinarian also stated that any serious systemic effects from this insecticide with this type of exposure would not be expected. The APSS veterinarian further stated that in general, significant neurologic signs are not expected with the appropriate use of etofenprox in cats. Finally, the APSS veterinarian stated that ingestion may cause taste reaction (hypersalivation) or vomiting. The APSS veterinarian recommended the owner call back with questions.


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. A necropsy was unavailable as the cat had already been cremated. This product is to be used monthly, and the cat should have been taken to the veterinary clinic to investigate issues before using the product within two weeks of the first application.

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

Male

6. Age (provide a range if necessary )

5.0

7. Weight (provide a range if necessary )

10.0

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 - Lethargy
    • Symptom - Abnormal behaviour
    • Specify - Behavior change
  • Gastrointestinal System
    • Symptom - Loss of appetite
  • General
    • Symptom - Adipsia
    • 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

On June 30, 2019, the cat developed lethargy, a behavior change, inappetence, and adipsia. On July 2, 2019, the cat passed away. On July 10, 2019, the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated that etofenprox is an ether pyrethroid and that the median lethal dose (LD 50) is over 40,000 milligrams per kilogram (mg/kg). The APSS veterinarian also stated that any serious systemic effects from this insecticide with this type of exposure would not be expected. The APSS veterinarian further stated that in general and that significant neurologic signs are not expected with the appropriate use of etofenprox in cats. Finally, the APSS veterinarian stated that ingestion may cause taste reaction (hypersalivation) or vomiting. The APSS veterinarian recommended the owner call back with questions.


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. A necropsy was unavailable as the cat had already been cremated. This product is to be used monthly, the cat should have been taken to the vet clinic to investigate issues before using the product within two weeks of the first application.