New incident report
Incident Report Number: 2024-1097
Registrant Reference Number: 2023-CA-000472
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: NEW BRUNSWICK
PMRA Registration No. 33791 PMRA Submission No. EPA Registration No.
Product Name: Parapet K9 Praventa 360 for Medium Dogs 4.6-11kg, 3 Tubes
Yes
Unknown
Site: Animal / Usage sur un animal domestique
No
Animal's Owner
Dog / Chien
Jack Russell Terrier
1
Female
0.75
5.0
kg
Skin
Unknown / Inconnu
>8 hrs <=24 hrs / > 8 h < = 24 h
System
Unknown / Inconnu
Yes
Yes
Unknown
Unknown/Inconnu
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 14-Nov-2023, a 0.75 year old, approximately 5.0 kilogram, intact, female, Jack Russell Terrier dog, in unknown condition, with no known concomitant medical condition, was administered 0.5 tube of Parapet K9 Praventa 360 for Medium Dogs 4.6-11kg (Imidacloprid, Permethrin, Pyriproxyfen) via the topical route by the animal owner. This was an extra label use due to low dose being applied (partial tube). On 15-Nov-2023, the dog developed shaking, trembling, and lethargy. On 16-Nov-2023, the dog developed a head tilt and was brought to an emergency veterinarian for evaluation. The only abnormality noted on examination was a corneal scratch. The dog was prescribed meloxicam and unspecified eye drops and discharged. On 19-Nov-2023, the dog was bathed using an unspecified product. At some point between 16-Nov and 20-Nov-2023, the dog developed a bloated stomach. On 20-Nov-2023, the dog was taken to the primary veterinarian for evaluation and was started on intravenous fluids and an unspecified pain medication. Nystagmus was noted on exam. Unspecified blood tests and abdominal radiographs with barium contrast was performed. The radiographs revealed a possible gastrointestinal foreign body obstruction. Results of blood work were not provided. The dog was then transferred to an emergency veterinarian. Exploratory abdominal surgery was performed, but no gastrointestinal obstruction was identified. The dog remained hospitalized at the time of the report on 22-Nov-2023. Continuing therapies as advised by the attending veterinarian was recommended. No further information was received in this case.
Moderate
Assessment: This product has a wide margin of safety in dogs when applied as per label directions. The active ingredients are poorly absorbed across intact skin so systemic signs are not anticipated. The dog was under-dosed in this case as only one-half tube was applied, making severe signs related to the product even less likely. The initial signs of lethargy and shaking may have been related to a paresthesia response. Signs of corneal abrasion, head tilt, nystagmus, and stomach bloating are not expected nor are they consistent with the toxicological profile of the product. Other causes must also be considered. 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.