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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-3169

2. Registrant Information.

Registrant Reference Number: 2019-CA-00359

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: 769262

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

Domestic Animal

4. Date registrant was first informed of the incident.

04-NOV-19

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

15-SEP-19

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. 32588      PMRA Submission No.       EPA Registration No.

Product Name: PREVENTIC Topical Solution Medium Dog

  • Active Ingredient(s)
    • IMIDACLOPRID
    • PERMETHRIN

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

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 04 Nov 2019, sponsor was contacted to report an apparent adverse reaction to PREVENTIC (8.8% Imidacloprid/44% Permethrin) Topical Solution Medium Dog. According to a technician at (Clinic Name), the animal owner applied one dose of PREVENTIC Topical Solution topically to the dog on 15 Aug 2019 and one dose on 15 Sep 2019.

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

Unknown

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

9

7. Weight (provide a range if necessary )

8.3

kg

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

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Grass ingestion
  • Gastrointestinal System
    • Symptom - Vomiting

12. How long did the symptoms last?

Unknown / Inconnu

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

Fully Recovered / Complètement rétabli

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 04 Nov 2019, sponsor was contacted to report an apparent adverse reaction to PREVENTIC (8.8% Imidacloprid/44% Permethrin) Topical Solution Medium Dog. According to a technician at (Clinic Name), the animal owner applied one dose of PREVENTIC Topical Solution topically to the dog on 15 Aug 2019. An unspecified amount of time later the dog began eating grass and vomited. The event was self-limiting. The animal owner applied the next monthly dose of PREVENTIC Topical Solution topically to the dog on 15 Sep 2019. The dog began eating grass and vomited an unspecified amount of time later; no resolution details were provided. The animal owner had contacted the clinic to inquire if they should apply the next dose of PREVENTIC Topical Solution, as it was overdue, or discontinue application. The dog was not vomiting at that time. Sponsor veterinarian discussed that it was highly unlikely that a topically applied product would cause vomiting and recommended the animal owner consult with the veterinarian regarding trying a different pesticide product. The technician reported that the dog had not been examined since 2017, and was reported to be low energy generally, and that the animal owners were reluctant to seek veterinary consult. No further information is expected.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

Sponsor veterinarian notes it is unlikely this is a true adverse reaction to PREVENTIC Topical Solution due to the active ingredient's mode of action, unless the product was ingested orally by the dog.