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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-1800

2. Registrant Information.

Registrant Reference Number: 120155372

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.

07-NOV-12

5. Location of incident.

Country: UNITED STATES

Prov / State: MICHIGAN

6. Date incident was first observed.

07-NOV-12

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. 2724-404-270

Product Name: Adams Plus Flea And Tick Mist With Precor For Use Only On Dogs Cats

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration .27 %
    • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
      • Guarantee/concentration .62 %
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration .37 %
    • PYRETHRINS
      • Guarantee/concentration .2 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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 November 6, 2012 the owner sprayed the dog's head and chin with the product.

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

French Bulldog

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 )

27.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Drooling
  • Nervous and Muscular Systems
    • Symptom - Trembling
  • Eye
    • Symptom - Other
    • Specify - Blinking
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

Unknown

14. a) Was the animal hospitalized?

Unknown

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 November 7, 2012 the owner noticed that the dog was symptomatic. Later that morning, the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that normally the product would be well tolerated, and that the owner might be seeing a mild taste reaction if the dog licked some of the product from his fur. The APSS veterinarian also stated that blinking would not be expected unless the product had been sprayed into the air in front of the dog's face and settled into the dog's eye. The APSS assistant recommended that the owner give the dog a taste treat of 2 tablespoons of milk, take the dog to the veterinarian if signs persisted, have the veterinarian call for information, call back with questions, and call back with the agent information when she got home.


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 November 12, 2012 an APSS assistant called the owner to update the case. The owner stated that the dog died on November 10, 2012 and that on an unknown date the dog was seen by a neurologist, who suspected that the dog had meningitis. The APSS veterinarian stated that meningitis was considered to have a medium likelihood of causing the clinical situation, based on the owner's neurologist's diagnosis. A necropsy was not available.