New incident report
Incident Report Number: 2017-4032
Registrant Reference Number: USA-BAYERBAH-2017-US0012433
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: TENNESSEE
PMRA Registration No. PMRA Submission No. EPA Registration No. Unknown
Product Name: Seresto Collar unknown
Other (specify)
CollarYes
Unknown
Site: Animal / Usage sur un animal domestique
Unknown
Medical Professional
Dog / Chien
Shih Tzu
1
Female
10
8.528
kg
Skin
>24 hrs <=3 days / >24 h <=3 jours
>24 hrs <=3 days / >24 h <=3 jours
System
>24 hrs <=3 days / >24 h <=3 jours
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date in 2017, a 10 year old, 18.8 pound, neutered, female, Shih Tzu canine, in unknown condition, with concomitant medical conditions of elevated liver enzymes, and dermal mass on right flank, with history of mast cell sarcoma, had one Seresto Dog (unspecified) (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On 27-Mar-2017, the dog was examined by a veterinarian. The dog was vaccinated with unspecified vaccines and unknown bloodwork was performed. The dog continued to have elevated liver enzymes. On 31-Mar-2017, the dog exhibited dyspnea. The owner bathed the dog with an unspecified shampoo and the collar was removed. On 01-Apr-2017, the dog exhibited anorexia, adipsia, not defecating, and ataxia. No medical intervention was sought . On 02-Apr-2017, the dog died and no necropsy was performed. No more information is expected. Case is closed. Follow up received on 5th Apr 2017: On 27-Mar-2017, a 10 year old, 18.8 pound, neutered, female, Shih Tzu canine, in unknown condition, with concomitant medical conditions of elevated liver enzymes, and dermal mass on right flank, with history of mast cell sarcoma, had a routine examination by the veterinarian, vaccinated with unspecified vaccines and unknown bloodwork was performed;the concomitant elevated liver enzymes continued. On 28Mar2017, the dog had one Seresto Dog (unspecified) (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On 31-Mar-2017, the dog exhibited dyspnea. The owner bathed the dog with an unspecified shampoo and the collar was removed. On 01-Apr-2017, the dog exhibited anorexia, adipsia, not defecating, ataxia and collapsed after a walk. No medical intervention was sought. On 02-Apr-2017, the dog died and no necropsy was performed. No more information is expected. Case is closed.
Death
O - Unclassifiable/unassessable Reported signs dyspnoea, anorexia and adipsia are unspecific signs and may have various other causes. Not defecating is not expected after product application, in this case it may be associated with anorexia. Ataxia and collapse are not anticipated with appropriate topical product administration. No oral product exposure reported. Death is not expected following appropriate topical product application as inconsistent with products pharmacological profile. Oral exposure to the collar is not expected to cause serious signs either. An overdose of 5 collars around the neck was investigated in adult cats and dogs for an 8 months period and in 10 week old kittens and 7 week old puppies for a 6 months period without causing serious signs. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Animal involved in this case was geriatric and had concomitant condition of elevated liver enzymes, dermal mass on right flank, with history of mast cell sarcoma which likely have contributed to reported signs and outcome. Even though time to onset is consistent, most of the signs were observed after collar removal. Although a relation to the product is deemed unlikely taking the animal's underlying medical problems and the product's safety profile into account, considering that the final cause for death remains unknown, the case is considered as unassessable.