Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-6642

2. Registrant Information.

Registrant Reference Number: 150109443

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.

10-AUG-15

5. Location of incident.

Country: UNITED STATES

Prov / State: CALIFORNIA

6. Date incident was first observed.

10-AUG-15

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?

No

9. Application Rate.

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

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

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Beagle

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

5.0

7. Weight (provide a range if necessary )

33.0

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

• Nervous and Muscular Systems
  • Symptom - Seizure

• Gastrointestinal System
  • Symptom - Drooling
  • Symptom - Vomiting

• Nervous and Muscular Systems
  • Symptom - Ataxia
  • Symptom - Fasciculations

• Respiratory System
  • Symptom - Dyspnea
  • Symptom - Cyanosis

• Gastrointestinal System
  • Symptom - Diarrhea

• Nervous and Muscular Systems
  • Symptom - Agitation

• General
  • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

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 August 10, 2015 the dog had ingested an unknown amount of the bait sometime during the day. That evening, the owner took the dog to the veterinarian where he presented seizuring, hypersalivating, and vomiting. The attending veterinarian gave atropine and diazepam, then did an endotracheal intubation. The attending veterinarian then contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated methomyl is a hot carbamate insecticide with a narrow margin of safety. The APSS veterinarian also stated clinical signs include muscarinic signs: salivation, lacrimation, urination, defecation, dyspnea, emesis (SLUDDE), miosis, bradycardia, dyspnea (due to goblet cell secretions.). The APSS veterinarian further stated nicotinic signs include tremors, twitching, weakness and paresis. The APSS veterinarian additionally stated that onset is generally rapid. 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 recommended monitoring the dog at the veterinary facility for central nervous system (CNS) signs, cardiovascular function, respiratory signs, and gastrointestinal (GI) signs. The APSS veterinarian also recommended managing vomiting, providing fluid therapy, giving atropine (for bradycardia and bronchial secretions (0.1-0.2 milligrams per kilogram (mg/kg)), managing tremors (robaxin, valium, barbituates), giving diazepam (for seizures), monitoring for signs of aspiration, 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

Death

19. Provide supplemental information here

Later in the evening on August 10, 2015 the attending emergency veterinarian called the APSS stating that the dog was having another seizure. The dog presented ataxic and fasciculating with a heart rate of 130.0 beats per minute (bpm). The dog had dyspnea and cyanosis. Later the dog had diarrhea (in his kennel) and was agitated. The attending emergency veterinarian had given atropine, maropitant, diazepam, did an endotracheal intubation, and gave propofol and oxygen. The APSS veterinarian recommended monitoring the dog's body temperature and for signs of aspiration, providing symptomatic and supportive care, giving atropine (repeat as needed for increased bronchial secretions, but be careful not to over atropinize), giving methocarbamol, and diazepam. The dog's color had improved and his pulse ox was 97. On August 12, 2015 an APSS technician called the attending emergency veterinarian to follow-up the case and left a message. On August 14, 2015 an APSS assistant called the attending veterinary clinic to follow-up. The veterinary staff stated that the dog had died on August 12, 2015 at home and the attending veterinarian was not available and did not have time to consult with an APSS veterinarian regarding the dog's death. The veterinary staff member stated that they would fax over the records to the APSS and have the attending veterinarian call with any questions. A necropsy was not available. Extra label use-product is not to be applied in areas accessible by pets and children.