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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-3811

2. Registrant Information.

Registrant Reference Number: 100058577

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-10

5. Location of incident.

Country: UNITED STATES

Prov / State: OKLAHOMA

6. Date incident was first observed.

09-MAY-10

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 Dogs Less Than 15 Lbs

  • 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.

1.0055

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 9, 2010 the owner inappropriately applied the product onto the dog that was under the labelled minimum age.

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

Canine Domestic Unspecified

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.25

7. Weight (provide a range if necessary )

8

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Loss of appetite
  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Drooling
  • General
    • Symptom - Polydipsia
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

No

14. a) Was the animal hospitalized?

No

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 May 10, 2010 the APSS veterinarian stated the dog's signs are very non-specific and could be due to a number of other possibilities. The APSS technician relayed the APSS veterinarian's recommendation to the owner to bathe the dog with liquid dish washing detergent (LDWD), monitor the dog for continued signs, take the dog to the veterinarian if signs continue, 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

The APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. On May 11, 2010 the owner contacted the APSS to update the case. The owner stated that he had bathed the puppy with LDWD, but the puppy is still not eating and is continuing to lay around. The APSS technician recommended the owner apply Vitamin E to the application site, warm up canned dog food to help encourage the puppy to eat, and if he cannot take care of the puppy, take the puppy to the shelter to relinquish him. On May 19, 2010 an APSS assistant contacted the owner to follow up the case. The owner stated the puppy had died shortly after the speaking with the APSS on May 11, 2010. The puppy was abandoned and the caller had taken the puppy into his home. The caller suspects that the neighbor poisoned the dog. The product was not used according to label directions: do not use on puppies under 6 months of age.