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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-1029

2. Registrant Information.

Registrant Reference Number: 2015-CA-00159

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

Address: 3200 Meacham Blvd.

City: Fort Worth

Prov / State: TX

Country: United States

Postal Code: 76137

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

Human

4. Date registrant was first informed of the incident.

03-JUN-15

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

01-JUN-15

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. 2382-104

Product Name: Preventic Collar for Dogs 25"

  • Active Ingredient(s)
    • AMITRAZ

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

9

Units: %

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 06/03/2015, PROSAR was contacted by the reporter, an adult female and animal owner, to notified the registrant of an apparent adverse reaction to PREVENTIC (25/9% Amitraz) Tick Collar for Dogs. According to the reporter, she had applied the PREVENTIC collar topically to her dog on 05/29/2015.

To be determined by Registrant

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

Unknown

Subform II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Data Subject

2. Demographic information of data subject

Sex: Female

Age: >19 <=64 yrs / >19 <=64 ans

3. List all symptoms, using the selections below.

System

  • Skin
    • Symptom - Rash
    • Symptom - Pruritus
  • General
    • Symptom - Swelling
    • Specify - Swelling on face

4. How long did the symptoms last?

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

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

Yes

6. a) Was the person hospitalized?

No

6. b) For how long?

7. Exposure scenario

Non-occupational

8. How did exposure occur? (Select all that apply)

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

Unknown

10. Route(s) of exposure.

Unknown

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

>3 days <=1 wk / >3 jours <=1 sem

13. Provide any additional details about the incident (eg. description of the frequency and severity of the symptoms, type of medical treatment, results from medical tests, outcome of the incident, amount of pesticide exposed to, etc.)

On 06/03/2015, PROSAR was contacted by the reporter, an adult female and animal owner, to notified the registrant of an apparent adverse reaction to PREVENTIC (25/9% Amitraz) Tick Collar for Dogs. According to the reporter, she had applied the PREVENTIC collar topically to her dog on 05/29/2015. On approximately 06/01/2015, the reporter developed a rash with pruritus and swelling on her face. The reporter indicated that the PREVENTIC collar was the only new item introduced to the household and no one else in the home developed any clinical signs. The reporter had discussed the clinical signs with a pharmacist, whom informed her she was having an allergic reaction, and the reporter began taking an unspecified dose of antihistamines. As of contact, the reporters itching had resolved while the rash and swelling were persisting. PROSAR discussed that the reported event was not expected with routine use of the PREVENTIC collar and the reporter may have an unrecognized sensitivity to one of the active or associated ingredients, and rashes could have several causes. PROSAR recommended discontinuing use of the drug product, bathing the dog and washing its bedding if she thought the PREVENTIC collar was contributing to the reported signs. On 06/10/2015, PROSAR contacted the reporter seeking follow up information. The reporter stated her clinical signs were resolving and she had not sought medical attention. No further information is expected.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

Sponsor notes that it is unknown if this is a true adverse reaction to the PREVENTIC Collar due to the unknown exposure to the collar and the potential for the clinical signs to be attributed to an unknown cause.