Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-6168

2. Registrant Information.

Registrant Reference Number: 140108881

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.

28-AUG-14

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

28-AUG-14

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. 20118      PMRA Submission No.       EPA Registration No.

Product Name: Starbar Equine Premium Golden Malrin Fly Bait With Muscamone

• Active Ingredient(s)
  • (Z)-9-TRICOSENE
  • METHOMYL

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7. b) Type of formulation.

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 August 28, 2014 the dog ingested some of the Starbar bait that had been mixed with a rat and mouse bait and (Z)-9-Tricosene into soda to poison raccoons.

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Canine Domestic Unspecified

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.58

7. Weight (provide a range if necessary )

32.0

lbs

8. Route(s) of exposure

Oral

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Drooling

• Nervous and Muscular Systems
  • Symptom - Muscle tremors
  • Symptom - Seizure
  • Symptom - Recumbent

• Cardiovascular System
  • Symptom - Bradycardia

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

12. How long did the symptoms last?

>30 min <=2 hrs / >30 min <=2 h

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

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

Unknown

15. Outcome of the incident

Fully Recovered / Complètement rétabli

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 August 28, 2014 the dog developed hypersalivation and tremors, so the owner took the dog to the veterinarian, where he started to seizure and was recumbent. The attending veterinarian gave diazepam and then contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated the Starbar bait is a very potent carbamate and can cause classic salivation, lacrimation, urination, defecation, dyspnea, and emesis (sludde) signs with large amount of fluid in lungs. The APSS veterinarian also stated it is very responsive to atropine and diazepam if treatment started soon enough. The APSS veterinarian stated the rat and mouse bait is an anticoagulant, risk would depend on how much dog might have ingested. The APSS veterinarian stated the (Z)-9-Tricosene is a pheromone sex-attractant for houseflies and no problem is anticipated. The attending veterinarian stated the dog was bradycardic with a heart rate of 84.0 beats per minute (bpm) and had moist lung sounds. The APSS veterinarian recommended giving atropine (give 0.1-0.15 milligrams per kilogram (mg/kg), quarter intravenous (IV), rest intramuscular (IM)), giving fluid therapy (maintenance for support), diazepam (if needed), monitoring at veterinary facility (likely ready to go home by end of day, once no signs remain and no medication for at least 3-4 hours), monitor for respiratory signs, and calling back with questions.

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To be determined by Registrant

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

Moderate

19. Provide supplemental information here

The APSS veterinarian stated that the rat and mouse bait was not considered to be related to causing the clinical situation. The APSS veterinarian stated that the (Z)-9-Tricosene was not considered to be related to causing the clinical situation. On September 2, 2014 the attending veterinarian called the APSS to follow up the case. The attending veterinarian stated that on August 28, 2014 they had given the dog atropine, fluid therapy, and monitored the dog at the clinic for respiratory signs. The attending veterinarian also stated dog had fully recovered on August 28, 2014. Extra Label Use: Product not to be used in areas accessible by animals and children.