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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-3857

2. Registrant Information.

Registrant Reference Number: 110064761

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.

27-MAY-11

5. Location of incident.

Country: UNITED STATES

Prov / State: PENNSYLVANIA

6. Date incident was first observed.

19-MAY-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. 2724-796-270

Product Name: Bio Spot Defense Spot On Flea And Tick Control For Dogs Medium

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration 3.6 %
    • ETOFENPROX
      • Guarantee/concentration 30 %
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration 5 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

4.5

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 May 18, 2011 the owner applied the product to her dog.

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

Dog / Chien

3. Breed

Canine Domestic Unspecified

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

3.0

7. Weight (provide a range if necessary )

37.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Vomiting
  • Nervous and Muscular Systems
    • Symptom - Shaking
  • General
    • Symptom - Lethargy
  • Blood
    • Symptom - Blood urea nitrogen increased
    • Specify - Azotemia
  • 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?

Unknown

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 19, 2011 the owner noticed the dog was vomiting. On May 21, 2011 the dog's vomiting worsened and the owner rinsed the dog in water. On May 22, 2011 the dog began shaking severely and became lethargic. At an unknown date and time, the owner contacted a veterinarian, and on May 26, 2011 the owner took the dog to the veterinarian, where fluid therapy was provided on May 27, 2011. That day, the owner also stated the dog had azotemia, with elevated Blood Urea Nitrogen (BUN) and Creatitine levels, although no values were provided. Later on May 27, 2011 the owner contacted the Animal Product Safety Service to obtain help. The APSS veterinarian stated that topical use of synthetic pyrethroid-like flea preparations as per label directions was not expected to cause significant clinical signs. The APSS veterinarian stated that if the product is ingested via grooming, a taste reaction characterized by hypersalivation may occur, which can be resolved by feeding a taste treat to replace the bad taste. The APSS veterinarian recommended having the veterinarian call for information and calling 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

The APSS veterinarian stated that the substance was not related to causing the clinical situation. On May 30, 2011 an APSS assistant called the owner to update the case. The owner stated that the vomiting had improved, but continued in small amounts, so she was giving smaller meals and providing Famotidine to the dog. The owner also stated that the shaking had ended and that the dog's lethargy was much worse. On June 8, 2011, an APSS veterinarian contacted the owner to update the case. The owner stated that the dog had died on June 4, 2011 and she did not want a necropsy.