Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-0938

2. Registrant Information.

Registrant Reference Number: 090134186

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-DEC-09

5. Location of incident.

Country: UNITED STATES

Prov / State: ILLINOIS

6. Date incident was first observed.

02-DEC-09

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)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2724-497-270

Product Name: Bio Spot Spot On Flea and Tick Control for Medium Dogs 31-60 Lbs

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

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

2.011

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).

The owner applied the wrong sized dose product on November 1, 2009 and then again on December 1, 2009. An unknown shedding supplement was also given on December 2, 2009.

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

Dog / Chien

3. Breed

Labrador Retriever

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

3.5

7. Weight (provide a range if necessary )

64

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

• General
  • Symptom - Pacing
  • Symptom - Discomfort

• Gastrointestinal System
  • Symptom - Drooling

• General
  • Symptom - Vocalizing

• Gastrointestinal System
  • Symptom - Diarrhea
  • Symptom - Abdominal distension
  • Specify - Flatulence
  • Symptom - Vomiting

• Skin
  • Symptom - Rash

• Nervous and Muscular Systems
  • Symptom - Muscle tremors
  • Specify - Facial Tremors

• General
  • Symptom - Abnormal behaviour
  • Specify - Behavior Change

• Nervous and Muscular Systems
  • Symptom - Seizure

• Respiratory System
  • Symptom - Apnea
  • Specify - Apnea

• 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?

1

Day(s) / Jour(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 November 18, 2009 the owner noticed a mild rash on the dog's groin and took her to the veterinarian, who prescribed an antibiotic and an antihistamine. The rash started clearing up. On December 2, 2009 the owners took her to the veterinarian, where she received supportive care with fluids and medications. On December 3, 2009 the APSS veterinarian recommended monitoring the dog at home, discontinuing the product usage, and call back with questions. A follow up was not set up as signs were expected to be mild and self limiting.

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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 December 17, 2009 the owner called the APSS to update the case. At that time, the owner informed APSS of the repeated exposure to the Biospot agent. The owners stated on December 5, 2009 the neurological signs became worse so they took her back into the clinic, where she stayed overnight. On December 6, 2009 she suddenly had a seizure, stopped breathing sometime in the afternoon, and could not be revived. A necropsy was completed by another facility and some tissue fluid samples had been saved, but the dog had been cremated. The APSS veterinarian stated canine patients are less sensitive to the permethrin and do not develop central nervous signs from appropriate use. On December 21, 2009 an APSS assistant contacted the laboratory who had done a general necropsy, stains, and blocks of muscle tissue but recommended further testing as the initial testing was inconclusive. The necropsy results showed no significant gross pathologic alternations except for minimally rounded heart. Inflammatory diseases and infection causes were not recognized. Exposure to mycotoxins and other toxins were considered as a likely cause.