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: 2014-6146

2. Registrant Information.

Registrant Reference Number: 140125066

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.

02-OCT-14

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

28-SEP-14

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. 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

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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 September 28, 2014 a family member noticed a single flea on another dog and as a preventative measure, they applied a wrong dose of the vial between the pet's shoulder blades.

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

Dog / Chien

3. Breed

Chihuahua

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

3.0

7. Weight (provide a range if necessary )

5.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Agitation
    • Symptom - Muscle weakness
    • Specify - Hind Limb Weakness
    • Symptom - Muscle tremors
    • Specify - Hind Limb Tremors
  • Renal System
    • Symptom - Inappropriate urination
  • General
    • Symptom - Vocalizing

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 September 28, 2014 the dog became agitated immediately after the product was applied; so the owner bathed the dog shortly after. On September 29, 2014 the dog developed additional symptoms. A few hours later, the owner gave the dog diphenhydramine (gave twice daily to help calm pet down) and took the dog to the veterinarian. On October 2, 2014 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated the risk is for mild-moderate, self-limiting, dermal hypersensitivity/paresthesia ("pins and needles" feeling). The APSS assistant recommended having the veterinarian call for information as likely other factors are involved as we don't expect these signs and for this duration with this product's use.


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. On October 3, 2014 the emergency veterinarian called the APSS to discuss the case. The emergency veterinarian stated on October 1, 2014 the owner brought the dog back to the clinic where the dog was hospitalized, given methocarbamol (62.5 milligrams (mg) by mouth every 8 hours), fluid therapy (intravenously), methylprednisolone, and a chemistry profile was run (results within normal limits- no damage to liver or kidneys). The emergency veterinarian also stated a referral to a neurologist was being considered. The APSS veterinarian discussed paraesthesia from the product and that she would not expect signs to be continuing this far out. The emergency veterinarian stated there was no sign of irritation were the product was applied. The APSS veterinarian recommended bathing the dog with liquid dish washing detergent (LDWD) and applying vitamin E to the application site, but again the time frame for the signs are not consistent with what we usually see with reactions to topical flea products. The APSS veterinarian recommended a diagnostic evaluation, symptomatic and supportive care, and calling back with questions.