New incident report
Incident Report Number: 2020-3169
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
Domestic Animal
Country: CANADA
Prov / State: QUEBEC
PMRA Registration No. 32588 PMRA Submission No. EPA Registration No.
Product Name: PREVENTIC Topical Solution Medium Dog
Yes
Units: mL
Site: Animal / Usage sur un animal domestique
Medical Professional
Dog / Chien
Unknown
1
Male
9
8.3
kg
Skin
>1 mo <= 6 mos / > 1 mois < = 6 mois
Unknown / Inconnu
System
Unknown / Inconnu
No
No
Fully Recovered / Complètement rétabli
Treatment / Traitement
(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.
Minor
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.