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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-7519

2. Registrant Information.

Registrant Reference Number: 160106852

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.

21-JUL-16

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW YORK

6. Date incident was first observed.

12-JUL-16

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. 2724-813-270

Product Name: Adams 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 July 7, 2016 the owner applied the product to treat fleas.

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

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8.0

7. Weight (provide a range if necessary )

15.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Skin
    • Symptom - Pruritus
    • Symptom - Erythema
    • Symptom - Lesion
    • Specify - Scab
  • Gastrointestinal System
    • Symptom - Diarrhea
  • General
    • Symptom - Hiding
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Loss of appetite
  • General
    • Symptom - Adipsia
    • Specify - Hypodipsia
  • Respiratory System
    • Symptom - Heavy breathing
  • Gastrointestinal System
    • Symptom - Retching
  • Nervous and Muscular Systems
    • Symptom - Seizure
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

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 July 12, 2016 the cat developed pruritus and scabs (owner also said something about sores/lesions). The cat then developed erythema and the owner applied hydrogen peroxide (H2O2) (has been applying 3 percent (%) H2O2 on a cotton swab to the irritated site almost once to twice a day). On July 15, 2016 the cat developed diarrhea. On July 16, 2016 the cat began hiding and was lethargic, but the pruritus seemed mild. On July 19, 2016 the cat developed inappetence and hypodipsia. On July 20, 2016 the cat developed heavy breathing. On July 21, 2016 the cat developed retching. Later that morning the cat's heavy breathing became worse. The owner then contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated etofenprox is an ether pyrethroid, the LD 50 is over 40,000 milligrams per kilogram (mg/kg) (Ag Chem). The APSS veterinarian also stated he would not expect any serious systemic effects from this insecticide with this type of exposure. The APSS veterinarian further stated in general, dermal application may cause a tingling sensation that results in ear twitching, hiding, hyperactivity, etc. The APSS veterinarian finally stated significant neurologic signs are not expected with the appropriate use of etofenprox in cats. The APSS assistant recommended taking the cat to the veterinarian and having the veterinarian call for information.


To be determined by Registrant

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

Death

19. Provide supplemental information here

On July 25, 2016 the APSS assistant called the owner to follow up on the case. The owner stated that the dog was taken to the veterinarian, started seizing, and then died on July 22, 2016. The owner declined speaking with an APSS veterinarian. Later that afternoon, an APSS technician called the owner to see if he was interested in a doing a necropsy. The APSS technician left a message asking the owner to call the APSS back if he was interested.