Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0167

2. Registrant Information.

Registrant Reference Number: 160120294

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.

14-AUG-16

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

14-AUG-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. 23852      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Flea Egg Collar for Cats

• Active Ingredient(s)
  • (S)-METHOPRENE

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Other Units: collar

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 August 13, 2016 the owner applied the flea collar onto the cat.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

1.0

7. Weight (provide a range if necessary )

10.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Difficulty walking
  • Symptom - Seizure
  • Symptom - Trembling
  • Symptom - Muscle tremors

• Skin
  • Symptom - Other
  • Specify - Warm Skin

12. How long did the symptoms last?

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

Treatment / Traitement

17. Provide any additional details about the incident

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

On August 14, 2016 the cat developed symptoms. Later that day, the cat had a seizure, then shortly after developed trembling (owner did not say when it started), so the owner then contacted the Animal Product Safety Service (APSS). During the call the cat developed tremors, and warm skin (cat feels hot, but temp is 38.6 degrees Celsius (C) (101.48 Fahrenheit (F)). The APSS assistant recommended the owner take the cat to the emergency veterinarian and have the veterinarian call the APSS to continue the case. The attending emergency veterinarian called the APSS to continue the case and stated the owner bathed the cat. The APSS veterinarian stated may see sensitivity to the collar material. The APSS veterinarian also stated methoprene is an insect growth regulator (IGR). The APSS veterinarian recommended obtaining additional information (any permethrin agents in home?), fluid therapy, monitoring for central nervous system (CNS) signs, methocarbamol (150 milligrams per kilogram (mg/kg) intravenously (IV) to effect; repeat as needed; try to stay below 330 mg/kg/day), monitor body temperature, and provide thermoregulation. The APSS veterinarian also recommended intralipid (recommend 20 percent (%) solution (no brand preference), use peripheral IV catheter, initial bolus at 1.5 milliliter per kilogram (ml/kg) over 5-10 minutes then 15 ml/kg x 30-60 minutes (CRI of 0.25 ml/kg/min), may need to extend CRI volume out longer in smaller patients, Stop IV fluids during this time, repeat in 4 hours (all step 2) provided there is no hyperlipemia, check for hyperlipemia before repeating the dose, do not repeat Intralipid dose if serum color is very orange/yellow; do not repeat until serum has become clearer (check serum color every 2 hours), do not give more than 3 doses if there has been no significant response after giving 3 doses, it may take several doses to see an improvement, there is a low risk of pancreatitis or hemolysis with this medication). The APSS veterinarian also recommended symptomatic care, supportive care, and calling back with questions. The APSS veterinarian called the attending emergency veterinarian to clarify the methocarbamol dosing- should be given to effect. The attending emergency veterinarian stated the cat was given diazepam and methocarbamol (50 mg/kg) and was doing much better. The attending emergency veterinarian did discuss the possibility of permethrin being the cause and the owner did come forth with using some of the dog product.

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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 substance was considered to have a doubtful likelihood of causing the clinical situation. The APSS veterinarian stated that permethrin was considered to have a medium likelihood of causing the clinical situation. On August 21, 2016 the APSS assistant called the attending emergency veterinarian to follow-up. The attending emergency veterinarian stated the cat received two doses of methocarbamol and was monitored for 12 hours. The attending emergency veterinarian also stated that when the cat was released he was eating and the trembling had stopped. The attending veterinarian finally stated the owner opted to take the cat home at that time as he could not afford further care.