Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-4972

2. Registrant Information.

Registrant Reference Number: 2018-CA-00134

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.

Domestic Animal

4. Date registrant was first informed of the incident.

10-MAY-18

5. Location of incident.

Country: CANADA

Prov / State: NOVA SCOTIA

6. Date incident was first observed.

04-MAY-18

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)

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PMRA Registration No. 32567      PMRA Submission No.       EPA Registration No.

Product Name: PREVENTIC Topical Solution

• Active Ingredient(s)
  • IMIDACLOPRID
  • PERMETHRIN

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

4

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 10 May 2018, sponsor was contacted to report an apparent adverse reaction to PREVENTIC (8.8 % imidacloprid, 44 % permethrin) Topical Solution XL Dog. According to the clinic staff with (name) Animal Hospital, the product was applied for the first time on 04 May 2018 to two dogs in the house.

To be determined by Registrant

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

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Labrador Retriever

4. Number of animals affected

2

5. Sex

Male

Female

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

75

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Skin
  • Symptom - Pruritus
  • Symptom - Dry skin
  • Specify - Flaky skin

• General
  • Symptom - Discomfort

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

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 10 May 2018, sponsor was contacted to report an apparent adverse reaction to PREVENTIC (8.8 % imidacloprid, 44 % permethrin) Topical Solution XL Dog. According to the clinic staff with (name) Animal Hospital, the product was applied for the first time on 04 May 2018 to two dogs in the house. Approximately 24 hours later it was reported that itching, flaking of the skin and discomfort at the application site were observed with both dogs. The animal owner bathed both dogs to aid in removal of the product on 06 May 2018. Sponsor attempted a follow-up attempt on 22 May 2018 with no resolution obtained in regards to the reported signs.

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To be determined by Registrant

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

Minor

19. Provide supplemental information here

Sponsor notes that individual sensitivities can be noted with use of product.