New incident report
Incident Report Number: 2018-2046
Registrant Reference Number: USA-BAYERBAH-2018-US0011491 (Report 477208)
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: UNKNOWN
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-141
Product Name: K9 AdvantixII small dog
Other (specify)
Spot-onYes
Units: mL
Site: Animal / Usage sur un animal domestique
Animal's Owner
Dog / Chien
Toy Poodle
1
Male
14
2.722
kg
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
Unknown / Inconnu
System
Persisted until death
Yes
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unknown date in 2015, post application, the dog was examined by a veterinarian and diagnosed with lymphoma. On unknown dates in 2016, the dog was examined by a veterinarian and administered intravenous unspecified chemotherapy medications daily. On an unknown date in 2016, the dog exhibited blindness. On 01 Jul 2017, the dog fell and died. No known necropsy was performed. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The reason for the initial communication was to discuss the expiration date of the product and not to report the death in this event. No more information is expected. This case is closed. Note: Previous exposure well tolerated.
Death
N-Unlikely: Reported lymphoma is not expected after product application, as inconsistent with pharmaco-toxicological product profile. Previous exposure well tolerated. Onset time not clarified, however other causes are likely in this geriatric dog. Later reported blindness, falling down and death are unexpected, other causes are likely (e.g. cataract, lymphoma, old age). For these signs, long onset time. Time for reporting is long, as intent of the phone call to Bayer was to discuss the expiration date of the product and not to report the death in this event. Considering known product safety profile, a product connection is deemed to be unlikely.