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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-4405

2. Registrant Information.

Registrant Reference Number: 130069975

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-13

5. Location of incident.

Country: UNITED STATES

Prov / State: OHIO

6. Date incident was first observed.

24-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. 2724-811-270

Product Name: Bio Spot Defense Flea And Tick Spot On For Extra Large Dogs 81 lbs +

  • 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.

9

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 23, 2013 the owner applied the product to the geriatric dog to treat for fleas.

To be determined by Registrant

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

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

American Bulldog

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

13.0

7. Weight (provide a range if necessary )

100.0

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

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

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Collapse
  • General
    • Symptom - Weakness
  • Gastrointestinal System
    • Symptom - Anorexia
    • Symptom - Abdominal distension
  • General
    • Symptom - Death
  • Nervous and Muscular Systems
    • Symptom - Muscle weakness
    • Specify - hind limb weakness

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 24, 2013 the owner noticed that the dog had an isolated incident of collapse and was weak, especially in her hind limbs, and the owner had to support her to keep her standing up. The owner immediately bathed the dog with a mild soap as directed by the product label. Later that evening, the owner noticed that the dog was anorexic. On May 27, 2013 the owner observed that the dog's abdomen was distended. Later that evening the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian said that the dog's signs would not be expected and were likely due to another cause. The APSS assistant recommended that the owner take the dog 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

The APSS veterinarian stated that the substance was not considered to be related to causing the clinical situation. On May 29, 2013 an APSS assistant called the owner to update the case. The owner stated that she was unable to get to the veterinarian and that the dog died suddenly on May 28, 2013. The owner mentioned that the dog had been acting different for some time prior to applying the product, but she did not give any details. A necropsy was not available. Unknown if veterinarian contacted prior to use on geriatric dog.