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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0080

2. Registrant Information.

Registrant Reference Number: 150023036

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: ALBERTA

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. 21206      PMRA Submission No.       EPA Registration No.

Product Name: Vet Kem Ovitrol Plus For Dogs And Cats

  • Active Ingredient(s)

7. b) Type of formulation.

Application Information

8. Product was applied?


9. Application Rate.


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 February 6, 2015 and again on February 10, 2015 the clinic applied a topical parasiticide onto the dog. On February 10, 2015 the owner applied the Vet Kem product onto the dog to treat for fleas.

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Border Collie

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

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

11. List all symptoms


  • Skin
    • Symptom - Pruritus
  • Gastrointestinal System
    • Symptom - Vomiting
  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Anorexia
  • Eye
    • Symptom - Other
    • Specify - Decreased Tear Production
  • General
    • Symptom - Hyperthermia
  • Eye
    • Symptom - Photophobia

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 February 11, 2015 the dog developed generalized pruritus. On February 14, 2015 the dog developed hyperthermia, with a temperature of 40.3 degrees Celsius (deg C). On February 17, 2015 the owner gave the dog Meloxicam at home. On February 19, 2015 the dog developed vomiting, lethargy, and anorexia. On February 20, 2015 the dog developed decreased tear production and the dog's temperature changed to 39.8 deg C. On February 21, 2015 the dog's hyperthermia ended, but she developed photophobia, so the owner took the dog to the veterinarian, where they started the dog on fluid therapy. The attending veterinarian then called the Animal Product Safety Service (APSS). The APSS veterinarian stated Vet Kem contains low concentrations of pyrethrins, synergists, and an insect growth regulator (IGR). The APSS veterinarian also stated toxicity is very low, even in felines and at most, some dogs may hypersalivate if it's groomed and may possibly vomit. The APSS veterinarian further stated she would not expect any risks for fever or Keratoconjunctivitis Sicca (KCS) though. The APSS veterinarian discussed non indicated drug (intralipids are not indicated in this case and bathing is not expected to be helpful) and recommended continuing treatment, diagnostic evaluation (for other etiologies), and calling back with questions.

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 Vet Kem was not considered to be related to causing the clinical situation. The APSS veterinarian stated that the topical parasiticide was not considered to be related to causing the clinical situation. A follow up was not performed, because these signs are not expected from the products and an immune-mediated disorder or an infection agent is possible; therefore, the outcome of this case is unknown.