New incident report
Incident Report Number: 2018-4947
Registrant Reference Number: 2018RB085
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson Blvd
City: Mississaugua
Prov / State: ON
Country: Canada
Postal Code: L4W 5R6
Human
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
Unknown
Medical Professional
Sex: Female
Age: Unknown / Inconnu
System
Unknown / Inconnu
No
No
Non-occupational
Application
None
Skin
Unknown / Inconnu
>8 hrs <=24 hrs / > 8 h < = 24 h
The pet owner had some of the product on her hand and wiped her nose and experienced a stinging sensation on her upper lip and then developed a blister and rash. The rash has improved but has not resolved. No medical treatment was provided. The dog also experienced an adverse reaction (linked report).
Minor
B - Possible Accidental direct and indirect exposure. Affected area is not fully compatible with exposed area, however as patient wiped nose with exposed hand, transfer to upper lip may have occurred. Reported stinging sensation is consistent with paresthesia induced by permethrin. Although a rash may occur in individuals with dermal sensitivity (mainly following direct product exposure), blister development is not expected and other causes should be considered. Time to onset is consistent. In the end, a product relation is considered possible. Preliminary assessment. Pending the final assessment after evaluation by Medical Doctor. If assessment is changed, the final statement will be submitted.
Medical Professional
Dog / Chien
Crossbred
1
Male
7
9.2
kg
Skin
Unknown / Inconnu
<=30 min / <=30 min
System
Unknown / Inconnu
Yes
No
Unknown/Inconnu
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
The dog immediately began scratching at the application site, was distressed, and was painful at the application site. The application site looked red, irritated, and raw. The pet owner applied polysporin and administered Benadryl. On June 6, 2018 the pet owner took the dog to the veterinarian who noted a moist exudative dermatitis at the application site and the skin at the application site was thickened. Cytology was performed and cocci with neutrophils were observed. The area was clipped and cleaned and the dog was prescribed cephalexin and prednisone and daily cleaning with chlorhexadine was recommended. The outcome is unknown.
Moderate
B - Possible Whereas skin reaction at application site, e.g. scratching and reddening may occur in sensitive animals, would not expect pain, irritation, raw, and further reported moist exudative dermatitis and thickening directly related to product. However, likely linked to scratching at application site which caused signs by self-trauma, which secondarily became infected with bacteria. Distress likely associated with other reported application site skin disorders. Considering consistent time to onset, a product connection is deemed to be possible.