New incident report
Incident Report Number: 2023-4130
Registrant Reference Number: 2023-CA-000231
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: ONTARIO
PMRA Registration No. 33791 PMRA Submission No. EPA Registration No.
Product Name: Parapet K9 Praventa 360 for Medium Dogs 4.6-11kg, 1 Tube
Yes
Unknown
Site: Animal / Usage sur un animal domestique
Animal's Owner
Dog / Chien
Shih Tzu
1
Male
10
8.0
kg
Skin
>8 hrs <= 24 hrs / >8 h <= 24 h
>8 hrs <=24 hrs / > 8 h < = 24 h
System
>2 hrs <=8 hrs / > 2 h < = 8 h
No
No
Fully Recovered / Complètement rétabli
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 22-Jun-2023, a 10 year old, 8.0 kilogram, neutered, male, Shih Tzu dog, in unknown condition, with a concomitant medical condition of skin allergies, was administered 1 tube of Parapet K9 Praventa 360 for Medium Dogs 4.6-11kg, 1 Tube (Imidacloprid, Permethrin, Pyriproxyfen) via the topical route by the animal owner. The dog was also administered a non-company concomitant product of 16 milligram oclacitinib by the animal owner. On 23-Jun-2023, the dog developed twitching (at the application site), digging on the floor (behavioral disorder NOS), restlessness, agitation, panting, tongue sticking out (tongue protrusion), and vocalization. The dog was bathed with dish soap via the topical route by the animal owner. Approximately 7 hours later, the clinical signs resolved and the dog recovered without veterinary intervention. No further information was received.
Moderate
Assessment: The reported signs are consistent with paresthesia (tingling of the skin) that may occur in some animals following topical application of a pyrethroid insecticide, including permethrin. These signs tend to be mild and self-limiting. The twitching was noted at the product application site and more likely related to localized paresthesia and not true neurologic dysfunction. 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.