New incident report
Incident Report Number: 2018-6444
Registrant Reference Number: USA-BAYERBAH-2018-US0065599 (Report 531981)
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: UNITED STATES
Prov / State: CALIFORNIA
PMRA Registration No. PMRA Submission No. EPA Registration No. Unknown
Product Name: K9advantixII pipette size unknown
Other (specify)
Spot-onYes
Unknown
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Golden Retriever
1
Male
Unknown
Unknown
Skin
>1 mo <= 6 mos / > 1 mois < = 6 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
System
Persisted until death
Yes
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 15-Aug-2010, the dog exhibited intermittent seizures, was evaluated by a veterinarian, was diagnosed with an unspecified seizure disorder and was administered unspecified anti-convulsants by mouth daily. On unspecified dates in 2011 and 2012, the dog had the product applied monthly. On 01-Jul-2012, the dog had the product reapplied. On approximately 01-Aug-2012, the dog died and no necropsy was performed. Due to the sensitive nature of the communication, certain relevant details were not obtained, nor will such be sought. The reason for the initial communication was to discuss use of the product and not to report the death in this event. No further information expected. This case is closed.
Death
N - Unlikely It is known that, at recommended dosage, none of active ingredients in the product have the potential to provoke seizures in dogs neither alone nor in combination. Only mild neurological signs, e.g. tremors or ataxia, may occur even after licking. Dog tolerated previous applications well, without neurological signs. Onset time is rather long. Dog was diagnosed with a (not further clarified) convulsive disorder which likely caused the reported sign. Later reported death not expected in dog after product application, as inconsistent with pharmaco-toxicological product profile. Very low level of information (age, medical history and necropsy details not available). Very long time (6 years) for reporting as the reason for the initial communication was to discuss use of the product and not to report the death in this event. Other etiologies more probable. No signs of allergy/anaphylactic reaction reported. Occurrence of sign within window of allergic/anaphylactic reaction (within 1 day) unlikely, as would have been reported in close proximity. Onset time is too long. Other etiologies more probable. Considering all aspects, product connection deemed to be unlikely.