Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-1016

2. Registrant Information.

Registrant Reference Number: 160166467

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-16

5. Location of incident.

Country: UNITED STATES

Prov / State: CALIFORNIA

6. Date incident was first observed.

06-NOV-16

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)

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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 %

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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. - Out Home / Rés - à l'ext.maison

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

On November 6, 2016 the puppy was outside for 30-40 minutes. The owner came home from the emergency clinic and noticed the bait was near the trash and the owner was concerned that the puppy had ingested it. Product is not to be applied in areas accessible to pets.

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 )

0.25

7. Weight (provide a range if necessary )

30.0

lbs

8. Route(s) of exposure

Oral

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Drooling

• Nervous and Muscular Systems
  • Symptom - Seizure

• Respiratory System
  • Symptom - Abnormal lung sounds
  • Specify - Moist Lung Sounds

• 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 6, 2016 the puppy developed symptoms. The owner attempted to take the puppy to the emergency veterinarian, but the puppy died on the way to the clinic. On November 7, 2016 the owner contacted the Animal Product Safety Service (APSS) as she was concerned the dog ingested the bait and had some questions about the bait. The APSS veterinarian stated methomyl is a carbamate that is rapidly absorbed after ingestion, but does not accumulate in the tissues. The APSS veterinarian also stated it does not "age" on the receptors like opiates (OP's) do, so signs are often short-lived. The APSS veterinarian additionally stated signs occur within minutes after ingestion, and include salivation, lacrimation, urination, diarrhea, dyspnea, emesis (SLUDDE) signs, bradycardia, ataxia, weakness, tremors, seizures, and possibly death. The APSS veterinarian finally stated if not a lethal exposure, signs are expected to resolve spontaneously due to the reversible nature of carbamate toxicity. The APSS veterinarian discussed the case with the owner and let her know that the signs and timing fit with the product. A necropsy was not available.

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To be determined by Registrant

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

Death

19. Provide supplemental information here

Off label use of the product. Product should not be accessible to dogs and humans.