New incident report
Incident Report Number: 2017-4016
Registrant Reference Number: USA-BAYERBAH-2017-US0020558
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: NEW YORK
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Collar Small
Other (specify)
collarYes
Other Units: cm
Site: Animal / Usage sur un animal domestique
Animal's Owner
Dog / Chien
Yorkshire Terrier
1
Male
4
2.722
kg
Skin
Unknown / Inconnu
Unknown / Inconnu
System
>3 days <=1 wk / >3 jours <=1 sem
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date in 2016, a 4 year old, 6 pound, male, Yorkshire Terrier canine, in unknown condition, with no known concomitant medical conditions, who was bathed once a week in an unknown shampoo since an unknown date in 2016, had 1 Seresto Small Dog (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On approximately 28-Feb-2016, the dog was anorexic. On approximately 29-Feb-2016, the dog was examined by the veterinarian. The dog had an unspecified type of laboratory blood profile performed, had a positive test result for Lyme disease and was diagnosed with kidney disease. On approximately 6-Mar-2016, the dog died at home. It is unknown if a necropsy was performed.
Death
N - Unlikely Reported anorexia is unspecific and it is likely associated with the later diagnosed lyme disease. In this case, no ticks seen on dog. In case of attachment of ticks these will be killed and fall off the host within 24 to 48 hours after infestation without having had a blood meal, as a rule. However, attachment of single ticks and even sucking of blood and thus transfer of tick borne diseases cannot be excluded while the collar is worn and simply reflects the labeled claim of efficacy that is not 100% against ticks especially when infestation pressure is high. Thus, infection with tick borne diseases (lyme disease) despite wearing a collar can occur exceptionally and is consistent with the products claimed efficacy as addressed in the product information. Diagnosed kidney disease and further reported death are not expected after topical product application as inconsistent with pharmaco-toxicological product profile. Diagnosed kidney disease may be associated with diagnosed lyme disease. Oral exposure to the collar is not expected to cause serious signs either. Product has wide margin of safety. In this case, cause of death may probably be diagnosed lyme disease and kidney disease thus, sufficient information exists to rule out product involvement. Time to onset is unknown for initial reported signs but seems longer for death. Even though some information (e.g. health status and necropsy results) is not available, considering the known safety product profile and alternative causes identified, a product involvement is deemed to be unlikely.