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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-7162

2. Registrant Information.

Registrant Reference Number: 130007830

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-JAN-13

5. Location of incident.

Country: CANADA

Prov / State: YUKON TERRITORY

6. Date incident was first observed.

12-JAN-13

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. 26493      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Fleatrol Power Spot Flea and Tick Control For Dogs Over 14 kg

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

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

2

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 January 4, 2013 the owners applied the product to the dog.

To be determined by Registrant

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

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Siberian Husky

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

3.0

7. Weight (provide a range if necessary )

18.0

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Vomiting
  • General
    • Symptom - Lethargy
  • Liver
    • Symptom - Elevated liver enzymes
  • Renal System
    • Symptom - Bilirubinuria
    • Symptom - Other
    • Specify - Ketonuria
    • Symptom - Other
    • Specify - Urinary Casts

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 January 12, 2013 the owners noticed that the dog was symptomatic. On January 14, 2013 the owners took the dog to an emergency veterinarian, where a diagnostic evaluation was done; a canine pancreatic lipase immunoreactivity (CPLI) test came back negative. The emergency veterinarian also took radiographs that appeared normal. On January 17, 2013 the emergency veterinarian provided the dog with fluid therapy and did a urinalysis. On January 18, 2013 the emergency veterinarian ran a chemistry profile on the dog; the serum alanine aminotransferase was recorded as 513.0 units per liter (U/L), the serum alkaline phosphatase was recorded as 862.0 U/L, the serum aspartate aminotransferase was recorded as 96.0 U/L, and the urine specific gravity was recorded as 1.03. Based on these results, the emergency veterinarian diagnosed the dog with elevated liver enzymes, bilirubinuria, ketonuria, and urinary casts. Later that evening, the emergency veterinarian contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that dermal irritation or contact hypersensitivity could occur, as with any topical exposure, and that in addition some animals exhibit abnormal behavior in response to the dermal sensation (paresthesia) that may be associated with topical permethrin. The APSS veterinarian also stated that if the product were ingested, gastrointestinal (GI) upset and/or a taste reaction could occur. The APSS veterinarian recommended that the emergency veterinarian provide symptomatic and supportive care, do a diagnostic evaluation for leptospirosis or other findings, obtain additional information about whether the dog was exposed to liver toxins (the owner could also contact the APSS directly to discuss the case), and 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

The APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. A follow up was not performed, because signs were expected to be mild and self-limiting. Therefore, the outcome of this case is unknown.