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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-1013

2. Registrant Information.

Registrant Reference Number: 160163658

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.


5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.


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.


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)

7. b) Type of formulation.

Application Information

8. Product was applied?


9. Application Rate.


Units: mg/L

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 June 1, 2016 the owner applied the spot on product onto the geriatric dog to treat for fleas. It is unknown if veterinarian consulted before use on the geriatric dog.

To be determined by Registrant

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


Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed


4. Number of animals affected


5. Sex


6. Age (provide a range if necessary )


7. Weight (provide a range if necessary )



8. Route(s) of exposure


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


  • Skin
    • Symptom - Pruritus
  • Nervous and Muscular Systems
    • Symptom - Seizure
    • Symptom - Collapse
    • Symptom - Difficulty walking
    • Specify - limp
    • Symptom - Other
    • Specify - life-less
    • Symptom - Rigidity
    • Specify - rigid
    • Symptom - Other
    • Specify - paddling
  • General
    • Symptom - Vocalizing
    • Specify - vocal
  • Renal System
    • Symptom - Inappropriate urination
    • Specify - urinates on himself

12. How long did the symptoms last?

Unknown / Inconnu

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


14. a) Was the animal hospitalized?


14. b) How long was the animal hospitalized?

15. Outcome of the incident


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 June 1, 2016 the dog developed pruritus. On June 8, 2016 the dog had a seizure. On June 9, 2016 the owner took the dog to the veterinarian for a diagnostic evalulation (everything within normal limits (WNL)). On June 10, 2016 the owner the bathed the dog (vinegar water) and the dog's pruritus ended. On October 19, 2016 the owner bathed the pet with a flea and tick shampoo. The dog then began having 4-5 seizures a day (sometimes the pet collapses and is limp and almost life-less, but is still breathing with a normal heart rate. Other times the pet has a standard seizure episode where the pet becomes rigid, paddling, vocal, and urinates on himself), so the owner took the dog back to the veterinarian for another diagnostic evalulation (everything still within normal limits (WNL)). On October 31, 2016 the owner the bathed the dog (vinegar water) and the daily seizures changed to become mild. On November 2, 2016 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated dogs tolerate pyrethroids well and no life threatening signs are expected. The APSS veterinarian also stated pyrethroids can cause a "pins and needles" sensation or hyperesthesia, resulting in reluctance to move, mild tremors, paw shaking, ear twitching or facial fasciculations. The APSS veterinarian additionally stated some dogs will develop erythema and pruritis as well. The APSS technician recommended having the veterinarian call for information.

To be determined by Registrant

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


19. Provide supplemental information here

The APSS veterinarian stated that with the Zodiac spot on we may see dermal sensitivity and pruritis, but seizures are not typical and we would not expect persistent seizures. The APSS veterinarian stated that the cardiovascular disease was considered to have a medium likelihood of causing the clinical situation. On November 4, 2016 the attending veterinarian called the APSS. The APSS veterinarian reviewed the case with the attending veterinarian and the attending veterinarian stated the dog was started on phenobarbital earlier that morning. It is unknown if a veterinarian consulted before use of product on geriatric dog.