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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-0780

2. Registrant Information.

Registrant Reference Number: 130156867

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.

11-NOV-13

5. Location of incident.

Country: UNITED STATES

Prov / State: WYOMING

6. Date incident was first observed.

11-NOV-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. 2724-274

Product Name: Starbar Golden Malrin Fly Bait 1% Methomyl

  • Active Ingredient(s)
    • (Z)-9-TRICOSENE
      • Guarantee/concentration .049 %
    • METHOMYL
      • Guarantee/concentration 1 %

7. b) Type of formulation.

Bait

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

10. Site pesticide was applied to (select all that apply).

Site: Res. - In Home / Rés. - à l'int. maison

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

On November 11, 2013 the owner noticed that the dog had accidentally ingested an unknown amount of the product that had been placed in the garage.

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 )

0.50

7. Weight (provide a range if necessary )

50.0

lbs

8. Route(s) of exposure

Oral

9. What was the length of exposure?

>15 min <=2 hrs / >15 min <=2 h

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Trembling
  • Gastrointestinal System
    • Symptom - Drooling
  • General
    • 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?

Accidental ingestion/Ingestion accident.

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

On November 11, 2013 the owner noticed that the dog was symptomatic. Several minutes later the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that Methomyl is a carbamate with a narrow margin of safety and that the risk was for muscarinic signs consisting of excessive salivation, lacrimation, urination, and defecation, and for nicotinic signs consisting of tremors, seizures, twitching, weakness, and paresis progressing to paralysis. The APSS veterinarian also stated that death is usually due to increased bronchial secretions leading to pulmonary edema. The APSS assistant recommended that the owner take the dog to the veterinarian and have the veterinarian call for information.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

Later on the evening of November 11, 2013 the owner's emergency veterinary staff contacted the APSS to discuss the case and treatment plan; the dog had not arrived at the clinic yet. The APSS veterinarian recommended that the emergency veterinarian give the dog a physical examination, Methocarbamol, Diazepam, fluid diuresis, 0.1 to 0.2 milligrams per kilogram (mg/kg) of Atropine intravenously for muscarinic signs, obtain a chemistry profile, and call back with questions. A short time later that evening the emergency veterinary staff contacted the APSS to update the case. The emergency veterinary staff stated that the dog was dead on arrival at the clinic. The APSS veterinarian repeated the recommendation to call back with any additional questions or concerns. A necropsy was not available. Extra Label Use: product is not to be used where it is accessible to pets.