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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-4402

2. Registrant Information.

Registrant Reference Number: 130061165

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.

10-MAY-13

5. Location of incident.

Country: UNITED STATES

Prov / State: FLORIDA

6. Date incident was first observed.

10-MAY-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. 2724-497-270

Product Name: Bio Spot Spot On Flea And Tick Control For Large Size Dogs over 60LBS

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration 3 %
    • PERMETHRIN
      • Guarantee/concentration 45 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

.5

Other Units: count

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 May 10, 2013 the owner inappropriately applied the product to the cat.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

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 )

3.0

7. Weight (provide a range if necessary )

6.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>2 hrs <=8 hrs / >2 h <=8 h

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Muscle tremors
  • Eye
    • Symptom - Decreased pupillary light reflex
    • Specify - Absent Pupillary Light Reflex
  • Nervous and Muscular Systems
    • Symptom - Coma
  • Eye
    • Symptom - Corneal abrasion
    • Specify - Corneal Ulceration
  • 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?

19

Hour(s) / Heure(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 May 10, 2013 the owner noticed that the cat was having tremors. Later that afternoon the owner bathed the pet. The owner also contacted the Animal Product Safety Service (APSS) that afternoon to obtain help; the owner stated that the cat's tremors had become milder. The APSS veterinarian stated that cats do not tolerate permethrin well and that drooling, ataxia, tremors, seizures, and possibly death could be seen. The APSS assistant recommended that the owner provide thermoregulation by towel drying the cat to prevent shivering, take the cat to the veterinarian, have the veterinarian call for information, and monitor the cat at home.


To be determined by Registrant

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

Death

19. Provide supplemental information here

On May 11, 2013 the owner's regular veterinarian contacted the APSS to update the case. The owner's regular veterinarian stated that the cat arrived on the evening of May 10, 2013; the cat's temperature was normal at 102.0 degrees Fahrenheit and the cat's tremors had worsened again. The vet staff gave the cat 5 cubic centimeters (cc) of Methocarbamol intravenously to the cat initially and then gave another 5 cc in water rectally prior to the clinic closing, provided fluid therapy, and bathed the cat. Earlier in the morning on May 11, 2013 the vet staff observed that the cat's pupillary light reflex was absent, the cat was in a coma, and the cat had a corneal ulceration. The vet staff gave the cat 0.4 cc of Diazepam to the cat intravenously. The APSS veterinarian stated that given the cat's condition, there was a grave prognosis for survival. The APSS veterinarian recommended that the regular veterinarian provide symptomatic and supportive care; give a 20 percent (%) solution of intralipid at 1.5 milliliters per kilogram (mL/kg) intravenously over 10 minutes and then give 0.25 mL/kg/minute (min) every 30 to 60 minutes in a peripheral vein, repeating the process every 4 hours if the serum was clear and not discolored; and call back with questions. Later that morning the owner contacted the APSS to discuss the case. The APSS assistant recommended that the owner have her regular veterinarian call for information. A short time later that morning the owner's regular veterinary staff contacted the APSS to get more information and during that time the cat died. A necropsy was not available. This is a dog product and may be fatal when used on cats.