Nouvelle déclaration d'incident
No de la demande: 2019-3617
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2019-US0034881 (Report 576412)
Nom du titulaire (nom légal complet, aucune abbréviation): Bayer inc
Adresse: 2920 Matheson BLVD
Ville: Mississaugua
État: ON
Pays: Canada
Code postal /Zip: L5W5R6
Incident chez l'humain
Pays: UNITED STATES
État: TENNESSEE
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556155
Nom du produit: Seresto Collar unknown
Autre (préciser)
COLLARNon
Inconnu
Personne affectée
Sexe: Homme
Âge: >6 <=12 yrs / > 6 < = 12 ans
Système
>8 hrs <=24 hrs / > 8 h < = 24 h
Inconnu
Oui
4
Day(s) / Jour(s)
Non professionnel
Inconnu
Inconnu
Unknown / Inconnu
Unknown / Inconnu
On approximately, 15-Feb-2019, the boy experienced intermittent grand mal seizures, 1 episode of emesis that resolved approximately 5 minutes post onset and mental impairment. A toxicology blood screening panel and other unspecified blood panel were performed and were both within normal limits. The boy continued to have intermittent seizures and was examined by a pediatrician on emergency. Magnetic Resonance Imaging testing was performed of the brain with the results within normal limits. Approximately 12 hours post onset, the boy recovered. It was unknown if treatments were performed. The boy remained hospitalized for observation.On 19-Feb-2019, the boy was released from the hospital.On 26-Jun-2019, the boy had a follow up exam performed with a pediatric neurologist, anThis morning her son had an appointment with a pediatric neurologist. An electroencephalogram was performed and showed normal brain activity.
Majeure
N - Unlikely An individual was secondarily exposed to collar, when dog slept in the bed with the boy. Affected site is not in line with exposed site. Reported serious neurological signs are not expected with appropriate product use as not consistent with product's pharmacological profile. The collar is odorless and its active ingredients not volatile at room temperature. Other causes are more likely in individual with concomitant history of digestive tract disorders and elevated blood pressure. Further, emesis is not expected after product exposure, however in this case it may be a consequence of reported seizures. Though, time to onset is short. Considering, no oral exposure and known safety profile of the product and available information, an overall product involvement is unlikely.Preliminary assessment. Pending the final assessment after evaluation by medical doctor. If assessment is changed, the final statement will be submitted.