New incident report
Incident Report Number: 2021-0955
Registrant Reference Number: USA-BAYERBAH-2021-US0001975 (Report 683929)
Registrant Name (Full Legal Name no abbreviations): Elanco
Address: 150 Research Lane, Suite 120
City: Guelph
Prov / State: ON
Country: Canada
Postal Code: N1G 4T2
Domestic Animal
Country: UNITED STATES
Prov / State: UNKNOWN
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-142
Product Name: K9advantixII medium dog
Other (specify)
spot-onYes
Units: mL
Site: Animal / Usage sur un animal domestique
Animal's Owner
Dog / Chien
Pug
1
Female
13
6.804
kg
Skin
>1 mo <= 6 mos / > 1 mois < = 6 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
System
Unknown / Inconnu
Yes
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 31 Dec 2020, the dog began vocalizing. On 14 Jan 2021, the dog had the product reapplied and the dog began having multiple seizures lasting approximately 10 seconds each. On 16 Jan 2021, the dog was bathed in a liquid dish detergent. The clinical signs continued. On 20 Jan 2021, the dog began vomiting. On 21 Jan 2021, the dog was anorexic. The dog was not examined by a veterinarian and the clinical signs continued. Follow up received on 25th Jan 2021: On 31 Dec 2020, the dog began vocalizing. On 14 Jan 2021, the dog had the product reapplied and the dog began having multiple seizures lasting approximately 10 seconds each. On 16 Jan 2021, the dog was bathed in a liquid dish detergent. The clinical signs continued. On 20 Jan 2021, the dog began vomiting. On 21 Jan 2021, the dog was anorexic. The dog was not examined by a veterinarian and the clinical signs continued. Follow up received on 28th Jan 2021: On 25 Jan 2021, the dog was examined by a veterinarian and blood work performed was within normal limits. The dog was started on an uspecified oral anticonvulsant medication. On 26 Jan 2021, the dog died. No necropsy was performed. No more information is expected. This case is closed.
Death
O - Unclassifiable/unassessable Reported vocalisation is very unspecific and may have many other numerous causes. Although product (containing a type I pyrethroid) may cause mild transient neurological signs, however reported seizures are not expected following product use. Secondly, dermal absorption is minimal. Other causes should be considered, e.g. idiopathic epilepsy, trauma and neoplasm. Previous applications were tolerated well, without neurological signs. Although time to onset is consistent, convulsion may rather be coincidental. Vomiting unspecific and may have many potential causes. Neither oral exposure nor signs suggestive of it (e.g. hypersalivation) were reported. Time to onset is long. Other causes should be considered. Anorexia in this case may be associated with the reported vomiting. Further reported death after product application is not expected in dogs, as it is inconsistent with the pharmaco-toxicological profile of the product. Time to onset is more than 12 hours, therefore an allergic/anaphylactic-type reaction can be ruled out. Considering all aspect, a product connection is unassessable.