New incident report
Incident Report Number: 2019-7171
Registrant Reference Number: USA-BAYERBAH-2019-US0069604 (Report 612305)
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: VIRGINIA
PMRA Registration No. 29777 PMRA Submission No. EPA Registration No. 11556-141
Product Name: K9advantixII small dog
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto small dog
PMRA Registration No. PMRA Submission No. EPA Registration No. Unknown
Product Name: MGK Advantage Treatment Shampoo for Dogs and Puppies
Other (specify)
spot-onYes
Units: mL
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Terrier - Silky dog
1
Female
8
4.08
kg
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 01-Sep-2019, the collar was removed for an unknown reason. On 18-Oct-2019, the dog was administered 1 tube of K9 Advantix II Small Dog (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner. On 08-Nov-2019, the dog exhibited partial anorexia, walking difficulty, lethargy, urinary incontinence, hunched over hanging the head (abnormal posture) and then died. The dog was not evaluated by a veterinarian and no necropsy was performed. No further information is expected.
Death
K9advantix II small dog: Reported partial anorexia and lethargy are unspecific and may have multiple potential other causes in a dog. Though permethrin has the potential to cause mild, transient neurological disorders (e.g. walking difficulty) in particularly susceptible animals, it is not expected after long time to onset. Urinary incontinence, hunched over hanging the head and death are not expected, as it is inconsistent with the pharmaco-toxicological profile of the product. Other causes should be considered. Time to onset is more than 12 hours, therefore an allergic/anaphylactic-type reaction can be ruled out. Moreover, previous applications were well tolerated. Considering long time to onset (20 days) and no necropsy was performed, a product relation is considered unassesssable. Seresto Small dog collar: All observed signs started more than 2 month after collar removal. Reported systemic disorders, walking difficulty and urinary incontinence are reported long time after collar removal, thus not related to product. Later, death is not expected following appropriate topical product application as inconsistent with product's 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. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. Moreover, fatal sign was reported long time after collar removal. Considering all aspects, product involvement is unlikely. MGK Advantage Treatment Shampoo for Dogs and Puppies: None of the signs expected following appropriate use of the product. Even in case of oral ingestion would not expect severe sign like death. Product has a wide margin of safety. Moreover, in case of oral ingestion only small amounts are ingested and rather cause mild digestive tract disorders. In this case no oral ingestion witnessed or suspected. Product was well tolerated on a regular basis every two weeks over a period of approximately 7 months. Other products were administered concomitantly. Signs non-specific and rather related to impending death. Time to onset in this case unknown, since previous treatment date unknown. No necropsy performed. Overall, product relation rather unlikely, but due to insufficient information, product relation is considered unclassifiable.