Health Canada
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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-0924

2. Registrant Information.

Registrant Reference Number: 10-US-12938

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.

21-DEC-10

5. Location of incident.

Country: UNITED STATES

Prov / State: ILLINOIS

6. Date incident was first observed.

21-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.       PMRA Submission No.       EPA Registration No. 238224496

Product Name: Preventic Collar for Dogs

  • 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 2010/12/21 Sponsor was contacted by NAPCC to report an apparent adverse reaction to the Preventic (25" 9% Amitraz) Collar for dogs . The Collar was applied to the neck of the pet on 2010/11/13 at an 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

Pug

4. Number of animals affected

3

5. Sex

Female

6. Age (provide a range if necessary )

0.9

7. Weight (provide a range if necessary )

19

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

>1 mo <=2 mos / > 1 mois < = 2 mois

11. List all symptoms

System

  • Reproductive System
    • Symptom - Stillbirth

12. How long did the symptoms last?

Anticip. permanent/Permanence anticipée

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

Died

16. How was the animal exposed?

Other / Autre

specify Possibly in utero

17. Provide any additional details about the incident

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

Owner did not know that pet was pregnant until 2010/12/21 when bitch went into labor and presented to the veterinarian for a C-section. According to the report 6 puppies were delivered, 3 were deceased, 2 were malformed, and 1 was unknown. According to ASPCA Poison Control of which the report was initially received, and with information obtained from (name)t and MSDS, the ASPCA "would not be expecting developmental defects in pups given this type of exposure. It was noted that in lab animals the teratogenic dose is between 12-25mg/kg/day; In dogs, 1mg/kg to 1.5mg/kg would be expected to cause marked clinical depression". Also, they are "not concerned about exposure at this point, primary excretion route of any absorbed into dam would be via the urine. Some exposure might have occurred in utero, though it is unlikely related to the death of the 3 fetuses; should not affect the live-born". Additionally it was reported that the collar was used for the treatment of demodicosis and there is a warning on the label for use in pregnant animals.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Subform III: Domestic Animal Incident Report

1. Source of Report

Other

2. Type of animal affected

Dog / Chien

3. Breed

Pug

4. Number of animals affected

2

5. Sex

Female

6. Age (provide a range if necessary )

0.9

7. Weight (provide a range if necessary )

19

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

>1 mo <=2 mos / > 1 mois < = 2 mois

11. List all symptoms

System

  • Reproductive System
    • Symptom - Birth defect

12. How long did the symptoms last?

Anticip. permanent/Permanence anticipée

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?

15. Outcome of the incident

Died

16. How was the animal exposed?

Other / Autre

specify Possibly in utero

17. Provide any additional details about the incident

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

Owner did not know that pet was pregnant until 2010/12/21 when bitch went into labor and presented to the veterinarian for a C-section. According to the report 6 puppies were delivered, 3 were deceased, 2 were malformed, and 1 was unknown. According to ASPCA Poison Control of which the report was initially received, and with information obtained from (name)t and MSDS, the ASPCA "would not be expecting developmental defects in pups given this type of exposure. It was noted that in lab animals the teratogenic dose is between 12-25mg/kg/day; In dogs, 1mg/kg to 1.5mg/kg would be expected to cause marked clinical depression". Also, they are "not concerned about exposure at this point, primary excretion route of any absorbed into dam would be via the urine. Some exposure might have occurred in utero, though it is unlikely related to the death of the 3 fetuses; should not affect the live-born". Additionally it was reported that the collar was used for the treatment of demodicosis and there is a warning on the label for use in pregnant animals.


To be determined by Registrant

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

Death

19. Provide supplemental information here