Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0121

2. Registrant Information.

Registrant Reference Number: 150174425

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.

18-DEC-15

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

18-DEC-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. 26494      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Powerspot Flea And Tick Control For Dogs Under 14 kg (30 lbs)

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

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Units: mL

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 December 18, 2015 the owner inappropriately applied the dog product onto the cat to treat for fleas.

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

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2.5

7. Weight (provide a range if necessary )

5.0

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>2 hrs <=8 hrs / >2 h <=8 h

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Seizure
  • Symptom - Muscle tremors
  • Symptom - Unresponsive
  • Specify - Stupor

12. How long did the symptoms last?

Unknown / Inconnu

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

Yes

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Unknown/Inconnu

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 December 18, 2015 the cat developed seizures and tremors. Later that afternoon the owner took the cat to the veterinarian (regular), where fluid therapy, methocarbamol (220 milligrams (mg)), and diazepam (0.75 mg) was given. The veterinarian also bathed the cat (with dish detergent) and clipped the cat's hair. Later that afternoon, the owner took the cat to an emergency veterinarian, where fluid therapy (2 times maintenance) was started and the cat was given a bath. The owner then contacted the Animal Product Safety Service to establish a case. The APSS veterinarian stated cats do not tolerate permethrin and there are some individual variations in sensitivity. The APSS veterinarian also stated signs range from mild paresthesia, ataxia and tremors to seizures and signs can develop from almost immediately up to 72 hours post-exposure. The APSS veterinarian recommended the owner have the emergency veterinarian call to discuss the case. The emergency veterinarian called the APSS. The APSS veterinarian recommended methocarbamol (5 to 220 mg/kilogram (kg) intravenous (IV) for severe tremor/seizure activity, give 1/2 rapidly (not exceeding 2 mL/minute (min)), allow the animal to relax and then give to effect (repeat to max 330 mg/kg/day)), diazepam (0.5-1.0 mg/kg IV in 5-10 mg increments), propofol (6 mg/kg IV; in healthy animals 25% of the calculated dose is administered every 30 seconds until intubation is possible. After induction, duration of anesthesia is only 2.5-9.4 minutes. Maintenance anesthesia obtained using either inhalation agents or a continuous infusion of propofol at approximately 0.4 mg/kg/min. If anesthesia appears inadequate, a small bolus of 1 mg/kg followed by an increase in the infusion rate by 25%), and phenobarbital (6 mg/kg IV; give slowly (especially cats) not greater than 60 mg/min, tends to have slow onset and marked respiratory depression). The APSS veterinarian also recommended monitoring the cat's body temperature, which was measured as 102.5 degrees Fahrenheit (deg F), providing supportive and symptomatic care, and giving intralipid (recommend 20% solution (no brand preference). Initial bolus at 1.5 ml/kg then 0.25 ml/kg/min for 30-60 minutes. 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. Please record the following information in your patient record so that it can be collected on follow up: Time when each dose of intralipids were started; What dose was given, if different from our recommendation; How many doses were given; Time when signs resolved; Did the patient improve (no response, slightly, moderately, full recovery), and if so how long after administration; Any adverse effects noted). The emergency veterinarian stated the cat had developed stupor and the cat's blood pressure was measured at 105.0/80.0 millimeters of mercury (mm Hg).

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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

Off label use ; owner inappropriately applied dog product onto the cat.