New incident report
Incident Report Number: 2018-2047
Registrant Reference Number: USA-BAYERBAH-2018-US0011722 (Report 477298)
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson BLVD
City: Mississauga
Prov / State: ON
Country: Canada
Postal Code: L5W5R6
Domestic Animal
Country: UNITED STATES
Prov / State: UNKNOWN
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Small Dog
Other (specify)
COLLARYes
Other Units: Collar
Site: Animal / Usage sur un animal domestique
Animal's Owner
Dog / Chien
Shih Tzu
1
Female
14
5.851
kg
Skin
>1 mo <= 6 mos / > 1 mois < = 6 mois
>3 days <=1 wk / >3 jours <=1 sem
System
>2 mos and <=6mos />2 mois et <=6mois
Yes
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 26 Jan 2018, the dog had very dark urine and lethargy. On approximately 15 Feb 2018, the dog was examined by a veterinarian and blood work was performed and reveled increased pancreatic enzymes. No treatments were performed. Clinical signs continued. On 30 Mar 2018, the dog began vomiting and had difficulty breathing. The dog was examined by a veterinarian and the dog was administered and unknown amount of subcutaneous fluids and was administered an unspecified antibiotic injection. On 31 Mar 2018, the dog had a seizure and died at home. No necropsy was performed. No more information is expected. This case is closed.
Death
N-Unlikely: Reported dark urine is not an expected sign with appropriate topical product application. Lethargy is unspecific and may have various other causes. Reported digestive signs are unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility). Mild gastrointestinal signs may occur shortly after product application, but here time to onset is too long. No oral product exposure reported. Difficulty in breathing is not anticipated after product administration. The product is not anticipated to cause serious neurological disorders such as seizures after appropriate topical product administration as the controlled release mechanism assures release of only low doses of active ingredient at a time. Even with oral product exposure, seizures are not expected. Merely gastrointestinal signs would be possible. Various etiologies exist for seizure events or paroxysmal signs, e.g. heart disorder, development disorder, metabolic disorder, infection, intoxication, idiopathic epilepsy, trauma, neoplasms. 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. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Time to onset long. Other causes are more probable in this geriartric dog. Even though no necropsy is available, considering the known product profile sufficient information exists to conclude that the product did not cause the event and product involvement was ruled out.