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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-4594

2. Registrant Information.

Registrant Reference Number: 170090561

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.

31-MAY-17

5. Location of incident.

Country: UNITED STATES

Prov / State: IDAHO

6. Date incident was first observed.

27-MAY-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. 2724-813-270

Product Name: Adams Flea and Tick Spot On for Cats and Kittens 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 May 27, 2017 the owner applied the product to the cat for prevention.

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 Longhair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

13.0

7. Weight (provide a range if necessary )

6.0

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

<=30 min / <=30 min

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Agitation
  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Anorexia
  • Respiratory System
    • Symptom - Dyspnea
    • Specify - Abnormal Breathing
  • 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

On May 27, 2017, the cat developed agitation and tried rubbing the product off immediately after application and developed lethargy later that evening. On May 30, 2017 the cat developed anorexia and abnormal breathing and increased lethargy. A few hours later, on May 31, 2017 the cat's breathing was shallow, later that evening the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated that oral exposure can result in a taste reaction, but that respiratory signs are not expected. The APSS assistant recommended that the owner take the cat to a veterinarian, have the veterinarian call for information, and to 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. On June 5, 2017 an APSS assistant called the owner for a follow up and the owner noted the cat passed away at home on June 2, 2017. The APSS assistant called to inquire about a necropsy but the call disconnected. At the time of this report, a necropsy is not pending.