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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-2856

2. Registrant Information.

Registrant Reference Number: 130008800

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.


5. Location of incident.


Prov / State: OHIO

6. Date incident was first observed.


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.


PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2724-814

Product Name: Kirkland Signature Flea And Tick Control For Cats 5lbs + over

  • Active Ingredient(s)
      • Guarantee/concentration 3.6 %
      • Guarantee/concentration 40 %

7. b) Type of formulation.


Application Information

8. Product was applied?


9. Application Rate.


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).

Starting on September 15, 2012 and continuing once monthly until November 15, 2012 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?


Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Cat / Chat

3. Breed


4. Number of animals affected


5. Sex


6. Age (provide a range if necessary )


7. Weight (provide a range if necessary )



8. Route(s) of exposure


9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

>1 mo <=2 mos / > 1 mois < = 2 mois

11. List all symptoms


  • Gastrointestinal System
    • Symptom - Weight loss
  • General
    • Symptom - Parasitism
    • Symptom - Dehydration
  • Blood
    • Symptom - Anemia
  • Renal System
    • Symptom - Renal failure
  • Blood
    • Symptom - Hyperphosphatemia
    • Symptom - Hypokalemia
  • Renal System
    • Symptom - Other
    • Specify - Isosthenuria
    • Symptom - Other
    • Specify - Urinary Casts
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.


14. a) Was the animal hospitalized?


14. b) How long was the animal hospitalized?


15. Outcome of the incident


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 November 1, 2012 the owner noticed that the cat had lost weight. On January 21, 2013 the owner noticed that the cat had fleas and took the cat to her regular veterinarian. A chemistry profile was done and it was determined that the cat was dehydrated and the heart rate was recorded as 120.0 beats per minute (bpm); although that reading was normal, the veterinarian thought that perhaps the cat was actually bradycardic considering she was dehydrated and unwell. A short time later that morning, the owner's regular veterinarian contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that etofenprox is a non-ester pyrethroid and that its mechanism of action is similar to pyrethroids. The APSS veterinarian said that renal disease is not an expected clinical sign. The APSS veterinarian recommended that the regular veterinarian perform a diagnostic evaluation, provide symptomatic and supportive care, and call back with questions.

To be determined by Registrant

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


19. Provide supplemental information here

On January 22, 2013 the owner's regular veterinarian called the APSS to update the case. The regular veterinarian stated that the owner mentions that a fogger product had been used in the home as well, and the APSS veterinarian stated that the fogger was an unlikely cause. According to the treating veterinarian the cat was anemic; the blood urea nitrogen, serum creatinine, and serum phosphorous were all high, and the cat was determined to have azotemia, hyperphosphatemia; and hypokalemia; finally, the cat's urine specific gravity was recorded as 1.011 and the cat was determined to have isothenuria and urine casts. The APSS veterinarian recommended that the regular veterinarian provide fluid diuresis. On January 24, 2013 the owner's regular veterinarian called the APSS to say that the cat had died at home on January 23, 2013. The owner took the cat back to the regular veterinarian, where the kidneys were removed for a histopath. The APSS technician recommended that a necropsy also be performed. On January 25, 2013 an APSS technician contacted the owner's regular veterinarian to discuss a necropsy, and the regular veterinarian confirmed they were going to send the body for necropsy. Final results of the necropsy were received on February 8, 2013; COMMENTS: This animal has a chronic-active pancreatitis. Symptomolo0gy form the pancreatitis is suspected. The clinical history (blood chemistry) is suggestive of renal disease; however, kidneys and adrenal gland were removed prior to necropsy examination and were not available for examination. On February 12, 2013 the DVM reported that the histo on the kidneys showed glomerulo-nephropathy caused by immune complex deposition. According to the Veterinarian at APSS weight loss, presumed renal dz, and dehydration are not related to product exposure.