New incident report
Incident Report Number: 2018-6066
Registrant Reference Number: 2018CK091
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson Blvd
City: Mississaugua
Prov / State: ON
Country: Canada
Postal Code: L4W 5R6
Domestic Animal
Country: CANADA
Prov / State: ONTARIO
PMRA Registration No. 29778 PMRA Submission No. EPA Registration No.
Product Name: K9advantixII medium dog
Yes
Units: mL
Site: Animal / Usage sur un animal domestique
Medical Professional
Dog / Chien
Crossbred (Dog)
1
Female
12
10.5
kg
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>24 hrs <=3 days / >24 h <=3 jours
System
Unknown / Inconnu
Yes
No
Fully Recovered / Complètement rétabli
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
2 days later the owner noticed application site scabs and application site redness. the dog was treated with polysporin at the pet owners discretion. The dog was examined at a veterinary clinic on july 4th. greasy fur at the application site and a skin odour was also noted. no further treatment was prescribed. the dog is currently considered recovered
Moderate
B - Possible Whereas skin reaction at application site, e.g. redness may occur in sensitive dog, would not expect application site scabs directly related to product. However, may be linked to scratching at application site which caused sign by self-trauma, though pruritus was not reported. Later reported application site greasy fur is not expected either after appropriate topical product application. Skin odour after topical product administration is not anticipated. However, in this case sign may be associated with application site greasy fur. Though time to onset is long (6 days) for skin odour, it is consistent for application site signs. Considering application site involvement and overall aspects, a product connection is deemed to be possible.