Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-3174

2. Registrant Information.

Registrant Reference Number: 2020-CA-00134

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

Address: 1301 Solana Blvd., Building 2, Ste 2400

City: Westlake

Prov / State: TX

Country: United States

Postal Code: 76262

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

Domestic Animal

4. Date registrant was first informed of the incident.

14-MAY-20

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

13-MAY-20

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. 32589      PMRA Submission No.       EPA Registration No.

Product Name: PREVENTIC Topical Solution SM Dog - CAN

• 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 14 May 2020, sponsor was contacted to report an apparent adverse reaction to PREVENTIC (8.8% Imidacloprid/44% Permethrin) Topical Solution Small Dog. According to a technician at (Clinic Name), the animal owner applied one dose of PREVENTIC Topical Solution topically to the dog on 13 May 2020.

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

Miniature Pinscher

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

10

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

• Skin
  • Symptom - Pruritus
  • Symptom - Dry skin
  • Specify - Scales at application site

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?

No

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 14 May 2020, sponsor was contacted to report an apparent adverse reaction to PREVENTIC (8.8% Imidacloprid/44% Permethrin) Topical Solution Small Dog. According to a technician at (Clinic Name), the animal owner applied one dose of PREVENTIC Topical Solution topically to the dog on 13 May 2020. Approximately six hours later the dog developed scratching and on 14 May 2020 some scales were present at the application site due to the scratching. The animal owner inquired about bathing and the clinic recommended bathing the dog to remove the product and bringing the dog in for an examination of the application site. Sponsor veterinarian recommended applying vitamin E oil to the affected area. On 15 May 2020, sponsor attempted to contact the technician seeking follow-up information and left a voicemail requesting a return call. On 18 May 2020 the technician reported that the dog was doing much better and inquired how long to treat the area with Vitamin E oil. Sponsor attempted to contact the technician on 18 and 19 May 2020 and left a voicemail. No further information is expected.

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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

N/A