Health Canada
Symbol of the Government of Canada
Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-6920

2. Registrant Information.

Registrant Reference Number: 180120110

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.

15-JUL-18

5. Location of incident.

Country: CANADA

Prov / State: NEWFOUNDLAND

6. Date incident was first observed.

15-JUL-18

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)

PMRA Registration No. 31367      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

7. b) Type of formulation.

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

Domestic Unspecified Mix

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2.0

7. Weight (provide a range if necessary )

5.48

kg

8. Route(s) of exposure

Oral

9. What was the length of exposure?

Unknown / Inconnu

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 - Muscle tremors
  • Eye
    • Symptom - Pupil dilation
    • Specify - Mydriasis

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?

Yes

14. b) How long was the animal hospitalized?

Unknown

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 July 15, 2018, the owner gave 1.0 milliliter (mL) of this product orally. Several hours later, the dog developed tremors. That night, the owner took the dog to the emergency veterinarian. The dog developed mydriasis and his tremors had become moderate. The dog's heart rate was normal at 100 beats per minute (bpm). Soon after, the emergency veterinarian placed an intravenous (IV) catheter and then contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated that the risk is for drooling, vomiting, and oral paresthesia for oral exposures and that rarely in dogs, tremors may be seen when a product with a high concentration of permethrin is given orally. The APSS veterinarian also stated that permethrin is a synthetic pyrethroid insecticide that specifically targets the neurologic system of insects and that it has low toxicity in dogs. The APSS veterinarian further stated that some animals are more sensitive to the ingredients than others. Finally, the APSS veterinarian stated that if ingested there could be hypersalivation and nausea. The APSS veterinarian recommended the emergency veterinarian monitor at the veterinary facility (until normal without medicine (meds) for 6 hours (h)), do not give activated charcoal, provide fluid therapy (intravenous fluids (IVF)), monitor electrolytes, monitor urine color (especially if severe and long lasting tremors; may be at risk for rhabdomyolisis), manage tremors (Methocarbamol dose: pull up 100 milligrams per kilogram (mg/kg) and give to effect. Methocarbamol (Robaxin-V, Fort Dodge, 100 milligrams per milliliter (mg/mL) 20 mL or 100 mL vial): Dogs/cats 55 to 220 mg/kg IV for severe tremor/seizure activity, give 1/2 rapidly (not exceeding 2 milliliters per minute (mL/min)), allow the animal to relax, and then give to effect (repeat to max 330 milligrams per kilogram per day (mg/kg/day)), give diazepam (may need valium or midazolam in conjunction with methocarbamol), monitor for respiratory signs (depression - if exceed the ceiling dose of methocarbamol), monitor for central nervous system (CNS) signs, monitor for gastrointestinal (GI) signs, provide supportive care, manage vomiting (antiemetics as needed), and to call back with questions.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

This was extra label use of product. This product is labeled for topical applications to dogs.

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Domestic Unspecified Mix

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

9.0

7. Weight (provide a range if necessary )

5.74

kg

8. Route(s) of exposure

Oral

9. What was the length of exposure?

Unknown / Inconnu

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 - Muscle tremors
  • Eye
    • Symptom - Pupil dilation
    • Specify - Mydriasis

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?

Yes

14. b) How long was the animal hospitalized?

Unknown

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 July 15, 2018, the owner gave 1.0 milliliter (mL) of this product orally. Several hours later, the dog developed tremors. That night, the owner took the dog to the emergency veterinarian. The dog developed mydriasis and his tremors had become moderate. The dog's heart rate was normal at 100 beats per minute (bpm). Soon after, the emergency veterinarian placed an intravenous (IV) catheter and then contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated that the risk is for drooling, vomiting, and oral paresthesia for oral exposures and that rarely in dogs, tremors may be seen when a product with a high concentration of permethrin is given orally. The APSS veterinarian also stated that permethrin is a synthetic pyrethroid insecticide that specifically targets the neurologic system of insects and that it has low toxicity in dogs. The APSS veterinarian further stated that some animals are more sensitive to the ingredients than others. Finally, the APSS veterinarian stated that if ingested there could be hypersalivation and nausea. The APSS veterinarian recommended the emergency veterinarian monitor at the veterinary facility (until normal without medicine (meds) for 6 hours (h)), do not give activated charcoal, provide fluid therapy (intravenous fluids (IVF)), monitor electrolytes, monitor urine color (especially if severe and long lasting tremors; may be at risk for rhabdomyolisis), manage tremors (Methocarbamol dose: pull up 100 milligrams per kilogram (mg/kg) and give to effect. Methocarbamol (Robaxin-V, Fort Dodge, 100 milligrams per milliliter (mg/mL) 20 mL or 100 mL vial): Dogs/cats 55 to 220 mg/kg IV for severe tremor/seizure activity, give 1/2 rapidly (not exceeding 2 milliliters per minute (mL/min)), allow the animal to relax, and then give to effect (repeat to max 330 milligrams per kilogram per day (mg/kg/day)), give diazepam (may need valium or midazolam in conjunction with methocarbamol), monitor for respiratory signs (depression - if exceed the ceiling dose of methocarbamol), monitor for central nervous system (CNS) signs, monitor for gastrointestinal (GI) signs, provide supportive care, manage vomiting (antiemetics as needed), and to call back with questions.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

This was an extra label use of product. This product is labeled for topical applications to dogs.