New incident report
Incident Report Number: 2016-1029
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
Human
Country: CANADA
Prov / State: QUEBEC
PMRA Registration No. PMRA Submission No. EPA Registration No. 2382-104
Product Name: Preventic Collar for Dogs 25"
Yes
Units: %
Site: Animal / Usage sur un animal domestique
Unknown
Data Subject
Sex: Female
Age: >19 <=64 yrs / >19 <=64 ans
System
>1 wk <=1 mo / > 1 sem < = 1 mois
Yes
No
Non-occupational
Unknown
Unknown
Unknown / Inconnu
>3 days <=1 wk / >3 jours <=1 sem
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.
Minor
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.