New incident report
Incident Report Number: 2017-0703
Registrant Reference Number: 2017KP005
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: UNKNOWN
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-125
Product Name: advantage II medium dog
Liquid
Yes
Units: mL
Site: Animal / Usage sur un animal domestique
Other
Dog / Chien
Miniature Pinscher
1
Female
10
14
lbs
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>24 hrs <=3 days / >24 h <=3 jours
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 05Jul2014, the dog developed generalized pruritus. On 01Aug2014 the pruritus continued and the owner applied another tube of Advantage II Medium dog. Follow up received on 19th Oct 2016: On 01Aug2014, the pruritus continued and the product was re-applied. On an unknown date, in 2016, the dog was diagnosed with congestive heart failure and died. No known necropsy was performed. The communication was not to report this event, but to discuss a different dog in the household. No more information is expected. This case is closed.
Death
Generalized pruritus is not anticipated with topical product administration. If any, skin reactions would be localized at the application site. Congestive heart failure is neither expected nor inline with products pharmaco-toxicological profile. Death is inconsistent with pharmacotoxicological product profile and experience. Product has wide margin of safety. The oral LD50 in rat is 642 mg/kg BW. 20-fold over dosage tolerated by dogs without showing any side effect. The cause of death was a congestive heart failure. The product was reported to be used on the dog for a significant period of time with no issues. This is a geriatric animal. The communication was not to report this event, but to discuss a different dog in the household. Even though time to onset is short for pruritus, it is long for other signs. Finally, even though no necropsy was performed, Considering all aspects product relation is unlikely.