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: 2011-1170

2. Registrant Information.

Registrant Reference Number: 11-00014

Registrant Name (Full Legal Name no abbreviations): Virbac Animal Health

Address: 3200 Meacham Blvd.

City: Ft. Worth

Prov / State: Texas

Country: United States

Postal Code: 76137

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

02-JAN-11

5. Location of incident.

Country: UNITED STATES

Prov / State: FLORIDA

6. Date incident was first observed.

02-DEC-10

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. 24496      PMRA Submission No.       EPA Registration No. 2382-104

Product Name: Preventic Collar (9%/Amitraz)

  • Active Ingredient(s)
    • AMITRAZ
      • Guarantee/concentration 9 %

7. b) Type of formulation.

Other (specify)

Collar

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Other Units: Collar

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 November 15, 2010 Animal owner veterinarian applied the Preventic Collar 25" (9%/Amitraz) collar around the dogs neck at a unspecified time.

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

Other

2. Type of animal affected

Dog / Chien

3. Breed

Miniature Dachshund

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

9

7. Weight (provide a range if necessary )

20

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Abnormal feces colour
    • Symptom - Vomiting
    • Symptom - Anorexia
  • General
    • Symptom - Lethargy
  • Renal System
    • Symptom - Inappropriate urination
  • Nervous and Muscular Systems
    • Symptom - Difficulty walking
    • Specify - Difficulty jumping
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Died

16. How was the animal exposed?

Treatment / Traitement

specify dermal (wearing the collar)

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

On 1/2/11 sponsor was contacted by NAPCC to report an apparent adverse reaction after the use of Preventic (25?/9% Amitraz) Collar for Dogs. The collar was applied by the animal owner veterinarian, evidence exposure occurred on 11/15/10 and the exposure was dermal. No known oral ingestion or licking of the collar per animal owner. On 12/2/10 animal owner reports inappropriate urination (accidents in the house). On 12/20/10 the animal owner reports lethargy, anorexia and difficulty jumping. On 1/1/11 the animal owner reports the pet developed abnormal feces color and the pet vomited 1 time yesterday and one time today. NAPCC recommend the collar be removed from he pet, bathed and taken to the veterinarian. NAPCC suggested another disease process is occurring with the animal as this type of reaction after dermal exposure is not expected. On 1/5/11 sponsor was contacted by NAPCC to provide an update on patient case. The animal owner was contacted by NAPCC to obtain and update on patient. The animal owner stated the pet died at home on 1/4/11. It was reported that owner refused giving pet a bath, and refused taking pet to DVM and have DVM consult NAPCC. According to the NAPCC report because the time course was poorly consistent, the amount was poorly consistent, and the findings were somewhat consistent, the substance was considered to have low likelihood of causing the clinical situation. No more information expected.


To be determined by Registrant

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

Death

19. Provide supplemental information here