Events

Alerte De Sécurité sur HAP-91 Hydroxyapatite Technical Name: Bone Graft Registration Number ANVISA: 10405720001 Hazard Class: IV Affected Model: Paralelepipel 10x20x10 Serial Number Affected: 1404050-EN

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par JHS Laboratório Químico Ltda; JHS Laboratório Químico Ltda.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    2132
  • Date
    2016-12-29
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    The patient should be monitored. I followed the usual prophylaxis protocol after surgery. In case of worsening of the patient's condition (severe infection), the patient should undergo surgery to remove the material, curettage of the region where the product was grafted.
  • Cause
    Client medfix ortopédica ltda (cnpj 01.748.211 / 0002-50) contacted to inform that on 09/12/2016 a surgical procedure of tibial fracture was performed on a patient with the product hap-91 paralelepiped 10x20x10, lot: 1404050-en. but the same was overdue, since its validity was 11/2016. the product was sold by jhs laboratório químico ltda. in january 2015, still being expired.
  • Action
    Field Action Code 011/16 triggered under the responsibility of the company JHS Laboratório Químico Ltda. Company will collect for further destruction.

Device

HAP-91 Hydroxyapatite Technical Name: Bone Graft Registration Number ANVISA: 10405720001 Hazard C...

Manufacturer

JHS Laboratório Químico Ltda; JHS Laboratório Químico Ltda
  • Source
    ANVSANVISA