New incident report
Incident Report Number: 2020-5609
Registrant Reference Number: 2020-US-031683
Registrant Name (Full Legal Name no abbreviations): Wellmark International
Address: 100 Stone Road West, Suite 111
City: Guelph
Prov / State: Ontario
Country: Canada
Postal Code: N1G5L3
Domestic Animal
Country: UNITED STATES
Prov / State: KENTUCKY
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 2724-734-89459
Product Name: Four Paws Elite Aloe Ear Mite Treatment for Cats
Liquid
Yes
Unknown
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Cat / Chat
Unknown
1
Unknown
2
4.989
kg
Unknown
Unknown / Inconnu
>24 hrs <=3 days / >24 h <=3 jours
System
Persisted until death
Unknown
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
The animal owner applied the product to the cat for 5 days starting on an unknown date. After 3 days the cat developed anorexia and bizarre behaviour. The cat was evaluated by a veterinarian on an unknown date, unknown if treatments were performed, and the cat died 30 minutes after veterinary evaluation. According to the animal owner, their veterinarian thought the cat's signs were due to an allergic reaction. No further information is expected.
Death
Assessment: This product has a wide margin of safety. If ingested, mild GI upset such as anorexia is possible. Otic irritation may occur from product application. With inner ear irritation, ruptured eardrums, underlying ear mites, or diseases such as vestibular disease there is the potential for symptoms such as balance issues, head tilt, and behavioural changes such as hiding to develop. Death is not expected. Allergic reactions that result in death typically cause severe rapid onset of symptoms rather than the minor and moderate signs described. Further information from the treating veterinarian could have provided additional information about the cat's clinical signs, possible causes, and death. Necropsy may have also provided additional information but was not pursued. Other causes for the cat's death should be considered including infection, trauma, and underlying disease. The information contained in this report is based on self-reported statements provided to the registrant during email and 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.