New incident report
Incident Report Number: 2021-3196
Registrant Reference Number: USA-BAYERBAH-2021-US0019053 (Report 699960)
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: RHODE ISLAND
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-143
Product Name: K9advantixII large dog
Other (specify)
spot-onYes
Units: mL
Site: Animal / Usage sur un animal domestique
Animal's Owner
Dog / Chien
Beagle
1
Male
13
15.876
kg
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
Unknown / Inconnu
System
Unknown / Inconnu
Yes
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date in approximately 2012, the dog developed bilateral localized alopecia localized to the flanks. On an unspecified date in approximately 2012, the dog was evaluated by a veterinarian and was diagnosed with an unspecified food allergy. On an unspecified date in approximately 2013, the dog developed an unspecified dermal cancer (Skin and/or appendage neoplasm NOS), was re-evaluated by a veterinarian, and was administered unspecified skin cancer treatments by the veterinarian. On an unspecified date in 2014, the dog developed hearing and vision loss. The dog was re-evaluated by a veterinarian, was diagnosed with an unspecified systemic cancer, and died. A necropsy was not performed.
Death
O - Unclassifiable/unassessable Reported localized alopecia is not expected after topical application of the product and may have other numerous causes (e.g., food allergy). Later reported food allergy, systemic and unspecified dermal cancer, hearing and vision loss are not expected after topical application of the product in dogs, as it is inconsistent with the pharmaco-toxicological profile of the product. The active ingredients are not listed as mutagenic or carcinogenic. Other etiologies are likely. Death may be likely due to reported underlying diseases in this geriatric patient. No signs of allergy/anaphylactic reaction reported. Time to onset is inconsistent. Moreover, the intent of the call was to inquire about product use in general and not to report this event. Although no necropsy performed, product involvement is not likely, however due to limited information regarding animal's state of health and initial onset time, case is considered unassessable.