Nouvelle déclaration d'incident
No de la demande: 2008-3367
Numéro de référence du titulaire d'homologation: US2008-01510
Nom du titulaire (nom légal complet, aucune abbréviation): Schering-Plough Canada Inc.
Adresse: 16750, Route Transcanadienne
Ville: Kirkland
État: Quebec
Pays: Canada
Code postal /Zip: H9H 4M7
Incident chez l'humain
Pays: UNITED STATES
État: MISSOURI
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 773-59
Nom du produit: Atroban 11%EC
Liquide
Non
Inconnu
Professionnel de la santé
Sexe: Homme
Âge: >64 yrs / > 64 ans
Système
>1 wk <=1 mo / > 1 sem < = 1 mois
Oui
Oui
Inconnu
Professionnel
Application
Autre
Inconnu
Peau
>2 hrs <=8 hrs / >2 h <=8 h
>2 hrs <=8 hrs / > 2 h < = 8 h
Human Exposure/ Adverse Event- Rocky Mountain Poison and Drug Center reported that a nurse from a Hospital reported that a patient,, was out spraying his cattle when his ATV rolled on approximately 7/7/08. The tank of Atroban 11% poured on him and he laid in the Atroban for 4 hours. He has dermal exposure and chemical burns to his upper body. On July 13, 2008 he started having swelling in the jaw area. The size of his face has doubled during the night. RMPDC reported that it is unlikely that the swelling that occurred 6 days post exposure is directly related to the product and that they should check with the MD. SPAH Veterinarian, reported that he spoke to the Hospital on July 17, 2008. They reported that the patient is still in the hospital in progressive care. He was moved over the weekend from ICU and has serious chemical burns and other injuries related to his accident. On July 21, 2008, SPAH Veterinarian followed up with the progressive care nurse. She reported that the patient sustained a fractured pelvis and other physical injuries in the accident as well as chemical exposure burns to his thorax, primarily his back. The nurse stated that the chemical burns were healing or healed and were not the patients major issues in his recovery. No further follow up required.
Majeure
Human Exposure/ Adverse Event- Rocky Mountain Poison and Drug Center reported that a nurse from a Hospital reported that a patient,, was out spraying his cattle when his ATV rolled on approximately 7/7/08. The tank of Atroban 11% poured on him and he laid in the Atroban for 4 hours. He has dermal exposure and chemical burns to his upper body. On July 13, 2008 he started having swelling in the jaw area. The size of his face has doubled during the night. RMPDC reported that it is unlikely that the swelling that occurred 6 days post exposure is directly related to the product and that they should check with the MD. SPAH Veterinarian, reported that he spoke to the Hospital on July 17, 2008. They reported that the patient is still in the hospital in progressive care. He was moved over the weekend from ICU and has serious chemical burns and other injuries related to his accident. On July 21, 2008, SPAH Veterinarian followed up with the progressive care nurse. She reported that the patient sustained a fractured pelvis and other physical injuries in the accident as well as chemical exposure burns to his thorax, primarily his back. The nurse stated that the chemical burns were healing or healed and were not the patients major issues in his recovery. No further follow up required.