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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6458

2. Registrant Information.

Registrant Reference Number: 130113289

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.

14-AUG-13

5. Location of incident.

Country: UNITED STATES

Prov / State: MICHIGAN

6. Date incident was first observed.

05-AUG-13

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 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.

1.804

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 August 5, 2013 the owner applied the product to 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

Russian Blue

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

6.0

7. Weight (provide a range if necessary )

19.0

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

<=30 min / <=30 min

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Drooling
    • Symptom - Weight loss
  • Nervous and Muscular Systems
    • Symptom - Abnormal posture
    • Specify - Head Held Low
  • General
    • Symptom - Lethargy
  • Renal System
    • Symptom - Inappropriate urination
  • General
    • Symptom - Pale mucous membrane colour
    • Specify - Abnormal Mucous Membrane Color
  • Nervous and Muscular Systems
    • Symptom - Seizure
  • General
    • Symptom - Death
  • Gastrointestinal System
    • Symptom - Loss of appetite
    • Specify - inappetent

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 August 5, 2013 the owner noticed that the cat had an isolated episode of drooling. On August 9, 2013 the owner noticed that the cat was inappetent and had lost weight; that day the dog in the home was started on aspirin crushed in his food, and the owner thought it was possible that the cat may have ingested some of it. On August 13, 2013 the owner noticed that the cat was holding his head low, was lethargic, and was urinating on himself. On the morning of August 14, 2013 the owner contacted the Animal Product Safety Service (APSS) to obtain help. During the consultation with the APSS, the owner was asked to evaluate the cat's gum color; the owner observed that the cat's gums and tongue appeared white and gray, instead of their normal pink color. The APSS technician recommended that the owner call back with questions, take the cat to the veterinarian, and have 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

The APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation and that aspirin was considered to have a low likelihood of causing the clinical situation. Later on the morning of August 14, 2013 the owner called the APSS to update the case. She stated that shortly after she spoke with the APSS that morning the cat had a seizure and died. The APSS veterinarian recommended that the owner consider pursuing a necropsy and to have her regular veterinarian call for information regarding a necropsy. On August 15, 2013 the owner's regular veterinary staff contacted the APSS to discuss a necropsy and the APSS veterinarian faxed necropsy instructions to the clinic. Later that day an APSS technician contacted the clinic to verify that they had received the necropsy submission forms; the clinic confirmed that they had and that the body had shipped that day. On August 21, 2013 gross necropsy results were received. The results revealed a marked flea infestation and presumptive mild anemia. The report stated that the cause of the cat's death was not apparent upon gross examination, and that a histopathology exam was in progress; results will be filed when they become available. The necropsy results were received on Aug 29 and though they were not able to find a cause of death, the results were suggestive of heart failure.