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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-6636

2. Registrant Information.

Registrant Reference Number: 150091054

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.

06-JUL-15

5. Location of incident.

Country: UNITED STATES

Prov / State: OREGON

6. Date incident was first observed.

03-JUL-15

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

Product Name: Zodiac Spot On Plus Flea And Tick Control For Cats 5 Pounds 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 29, 2015 the owner applied the product onto the cat to treat for 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 Longhair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

14.0

7. Weight (provide a range if necessary )

9.0

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

  • General
    • Symptom - Lethargy
  • Liver
    • Symptom - Elevated liver enzymes
  • General
    • Symptom - Pale mucous membrane colour
  • Cardiovascular System
    • Symptom - Hypotension
  • 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?

Yes

14. b) How long was the animal hospitalized?

1

Day(s) / Jour(s)

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 3, 2015 the cat became lethargic. Later that day the owner took the cat to the veterinarian where blood work was done. The cat then was diagnosed with elevated liver enzymes, pale mucous membrane color, hypotension, anemia, and treated with fluid therapy (intravenous (IV)). On July 5, 2015 the owner got a call from the clinic that the cat had died overnight. On July 6, 2015 the owner contacted the Animal Product Safety Service (APSS). The owner had questions on what could cause the severe anemia, so the APSS veterinarian discussed active hemorrhage, immune-mediated hemolytic anemia/immune-mediated thrombocytopenia (IMHA/ITP), neoplasia, etc. The owner stated the blood work was normal 2 months prior. The APSS veterinarian recommended a necropsy (cat was buried, may not be able to do necropsy) and having the veterinarian call for information (to discuss if necropsy is even a possibility and to discuss the case).


To be determined by Registrant

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

Death

19. Provide supplemental information here

On July 7, 2015 the attending veterinarian called the APSS to discuss the case. The attending veterinarian stated that the cat was a patient, but had not been seen in quite some time. The attending veterinarian discussed the case with the APSS veterinarian. The APSS veterinarian stated she does not feel that the signs are related to the exposure and that there was probably something else going on with the cat. The APSS veterinarian also stated that since the owner buried the cat, she would not recommend a necropsy.