New incident report
Incident Report Number: 2018-2073
Registrant Reference Number: USA-BAYERBAH-2018-US0015950 (Report 481106)
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson Blvd
City: Mississauga
Prov / State: ON
Country: Canada
Postal Code: L4W 5R6
Domestic Animal
Country: UNITED STATES
Prov / State: PENNSYLVANIA
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-144
Product Name: K9 Advantix II Extra Large Dog
Other (specify)
Spot-onYes
Units: mL
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Unknown
1
Unknown
Unknown
Unknown
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date in 2017, post application, the dog died. No necropsy was performed. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The intent of the call was not to report this event, but to inquire about the expiration date of the product and not to report the death in this event. Note: Previous application were well tolerated. Follow up information received on 26th April 2018: No more information is expected. This case is closed.
Death
N - Unlikely Reported death is not expected in dog after product application, as inconsistent with pharmaco-toxicological product profile. Very low level of information (age, unknown time to onset and necropsy not available) as the intent of the phone call to Bayer was to inquire about the expiration date of the product and not to report the death in this event. No signs of allergy/anaphylactic reaction reported. Even though time to onset is unknown, occurrence of sign within window of allergic/anaphylactic reaction (within 1 day) unlikely, as would have been reported in close proximity. Other causes are more probable. Moreover, previous exposure were well tolerated. Considering all aspects, a product connection is deemed to be unlikely.