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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-5861

2. Registrant Information.

Registrant Reference Number: 110120251

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.

18-SEP-11

5. Location of incident.

Country: UNITED STATES

Prov / State: WISCONSIN

6. Date incident was first observed.

17-SEP-11

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. 2724-404

Product Name: Zodiac Fleatrol Flea And Tick Spray For Dogs Cats Puppies And Kittens

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration .27 %
    • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
      • Guarantee/concentration .62 %
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration .37 %
    • PYRETHRINS
      • Guarantee/concentration .2 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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 September 17, 2011 the owner applied the product to his 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

Medical Professional

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 )

4.5

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>15 min <=2 hrs / >15 min <=2 h

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Fasciculations
  • 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 the evening of September 17, 2011 the owner noticed the cat was having fasciculations. A short time later, early on September 18, 2011 the owner observed the cat died on the way to the veterinarian. Later on the morning of September 18, 2011 the owner's emergency veterinarian contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that pyrethrin sprays have a good margin of safety in cats and that significant central nervous system (CNS) signs were not expected. The APSS veterinarian recommended that the emergency veterinarian obtain the EPA registration number of the product, have a necropsy done if the owner approved it, and call back.


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 September 18, 2011 the emergency veterinarian called the APSS to provide the EPA registration number. On September 19, 2011 an APSS technician contacted the emergency veterinarian to discuss a necropsy. On September 23, 2011 an APSS technician spoke with the emergency veterinarian and they confirmed the body had been sent for a necropsy. Later that day, an APSS technician spoke with the diagnostic laboratory staff to confirm the submission. On October 12, 2011 final necropsy information was received. Per necropsy results, the cat was infested with fleas, with extensive amounts of flea dirt on the skin; the cat was obese; the heart revealed moderate left ventricular concentric myocardial hypertrophy, the lung revealed mild diffuse pulmonary edema, the liver revealed subacute mild centrilobular hepatocyte degeneration and atrophy, the kidney revealed mild to moderate multifocal interstitial nephritis, the bone marrow revealed mild to moderate erythroid hyperplasia, the pancreas revealed moderate multifocal pancreatic islet amyloidosis, and the adrenal gland revealed focal cortical hyperplasia. The results indicated that the cause of death could be attributed to myocardial hypertrophy and insufficiency, resulting in the observed pulmonary edema. The results also indicated that there was evidence of centrilobular hepatocellular degeneration and atrophy that likely resulted from decreased right sided functions. The changes in the kidney are common in adult animals and their clinical significance was uncertain, but could reflect decreased renal function as well. The decreased cardiac output may have resulted in poor tissue perfusion and hypoxia, stimulating increased erythropoiesis in the bone marrow. The islet amyloidosis suggested the potential for diabetes mellitus. The adrenal hyperplasia was likely an incidental finding. The APSS veterinarian reassessed the case and stated that hypertrophic cardiomyopathy was considered to have a high likelihood of causing the clinical situation.