New incident report
Incident Report Number: 2024-1098
Registrant Reference Number: 2023-CA-000498
Registrant Name (Full Legal Name no abbreviations): Evergreen Animal Health, LLC
Address: 22655 Centennial Road
City: Gretna
Prov / State: Nebraska
Country: USA
Postal Code: 68028
Domestic Animal
Country: CANADA
Prov / State: UNKNOWN
PMRA Registration No. PMRA Submission No. EPA Registration No. Unknown
Product Name: Parapet K9 Praventa 360 for dogs (non-specific)
Yes
Unknown
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Cocker American Spaniel
1
Male
1
10.9
kg
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>3 days <=1 wk / >3 jours <=1 sem
System
Unknown / Inconnu
Yes
No
Unknown/Inconnu
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 27-Nov-2023, a 1 year old, approximately 10.9 kilogram, neutered, male, Cocker American Spaniel dog, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of Parapet K9 Praventa 360 for dogs (non-specific) (Imidacloprid, Permethrin, Pyriproxyfen) via the topical route by the animal owner. On 01-Dec-2023, the dog developed application site reddening and application site irritation. On 02-Dec-2023, the dog developed an application site lesion with purulent discharge. Veterinary evaluation was recommended due to the clinical signs. On 04-Dec-2023, the dog was evaluated by a veterinarian. The dog was prescribed a treatment regimen of an unspecified antibiotic, topical ointment, and topical spray and was discharged to the owner. As of 05-Dec-2023, the clinical signs improved but continued. No further information was received in this case.
Moderate
Assessment: Skin ulceration or open wounds are not anticipated simply from application of the product, but if the dog was persistently scratching at the application site skin damage or an open sore may occur. In this case it is possible the dog was sensitive to an ingredient in the product (active or inactive) as persistent scratching was not prescribed. The information contained in this report is based on self-reported statements provided to the registrant during telephone interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and cannot form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews.