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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-5710

2. Registrant Information.

Registrant Reference Number: 110099813

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.

03-AUG-11

5. Location of incident.

Country: UNITED STATES

Prov / State: WASHINGTON

6. Date incident was first observed.

30-JUN-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. 2724-504

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 30, 2011 and again on July 29, 2011 the owner applied the product to her cat to prevent 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 Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

10.0

7. Weight (provide a range if necessary )

12.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Adipsia
    • Symptom - Lethargy
    • Symptom - Hiding
    • Symptom - Vocalizing
  • Nervous and Muscular Systems
    • Symptom - Trembling
  • Renal System
    • Symptom - Other
    • Specify - Renal Disease
  • Nervous and Muscular Systems
    • Symptom - Muscle weakness
    • Specify - Hind Limb Weakness
  • Gastrointestinal System
    • Symptom - Drooling
  • Skin
    • Symptom -
    • Specify - Hyperesthesia
  • Blood
    • Symptom - Anemia
    • Symptom - Hyperphosphatemia
  • 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?

Unknown

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 June 30, shortly after the product was applied to the cat, the owner noticed he was anorexic, adipsic, lethargic, hiding, vocalizing, and trembling. About an hour later, the cat was no longer vocalizing. On July 1, 2011 the cat had isolated events of hind limb weakness and hypersalivation, and the cat also became hyperesthetic.. By July 5, 2011, all of the signs except for the hyperesthesia had ended. On July 18, 2011 the owner noticed the cat was anorexic again. On July 30, 2011 the owner applied the product to the cat again, and the cat once again was adipsic, lethargic, hiding, vocalizing, and trembling. On August 2, 2011 the owner took the cat to the veterinarian, where he was given vitamin B, fluid therapy, and Enrofloxacin. On August 3, 2011 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the product does not cause systemic effects, but that some cats may be sensitive to the carriers, or the active ingredients. The APSS veterinarian also stated that the signs often resolve within a few days and/or after bathing and that hypersalivation is common from the odor or from the taste of the product. The APSS veterinarian stated that renal damage would not be expected to be directly related to the product. The APSS assistant recommended that the owner bathe the cat with liquid dish washing detergent (LDWD) and rinse well, monitor the cat at home, apply a cold compress and vitamin E, give canned food, take the cat to the veterinarian, have the veterinarian call for information, and 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

On August 6, 2011 the owner contacted the APSS to update the case. The owner stated that at an unknown date and time she bathed the cat, monitored him at home, applied a cold compress and vitamin E, and gave canned food. The owner stated that on August 5, 2011 she took the cat to the veterinarian, where a chemistry profile revealed that the cat had renal disease and was in kidney failure. The APSS veterinarian recommended that the owner obtain additional information about lab values and if a urine specific gravity was done, have a urine specific gravity done by the regular veterinarian, take the cat to the veterinarian for fluids if he had renal disease, and call back. Later that day, the owner called back to update the case. The owner stated that the cat was anemic, with hematocrit measured at 24.5 percent volume to volume (% v/v). The owner also stated that the cat had elevated blood urea nitrogen, which was measured at 185.0 milligrams per deciliter (mg/dL); had elevated creatinine, with serum creatinine recorded as 11.6 mg/dL; and had hyperphospatemia, with serum phosphorus recorded as 12.3 mg/dL. On August 15, 2011 the owner called to update the case. The owner stated that the cat had been receiving subcutaneous fluids at home and that he died on August 18, 2011. A necropsy was not available. The veterinarian at APSS suspected that the cat had chronic issues developing for some time.