Events

Alerte De Sécurité sur STIMULATOR / NERVE LOCATOR, DISPOSABLE PULSATRON LL; IDENTIFIER: NO. CATALOG 82-62015;

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 MEDTRONIC XOMED SURGICAL PRODUCTS INC DIV MEDTRONIC INC.

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
    157
  • Date
    2000-06-19
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    The above mentioned nerve locator can operate intermittently, which may result in a lack of perception of stimulus when the nervous tissue is really touched by the stimulator. this false-negative response may be interpreted as the absence of nervous tissue. the manufacturer started a removal by correspondence dated of june 19, 2000.
  • Action
    MAKE SURE THAT YOU HAVE RECEIVED THE DATED CORRESPONDENCE OF JUNE 19, 2000 AND THE MEDTRONIC XOMED SURGICAL PRODUCTS CHECKLIST. IDENTIFY AND ISOLE ANY PRODUCT AFFECTED FROM YOUR INVENTORY USING THE CHECKLIST. RETURN THE PRODUCT AFFECTED FOR MEDTRONIC XOMED SURGICAL PRODUCTS AT THE ADDRESS REFERRED TO. MEDTRONIC XOMED SURGICAL PRODUCTS WILL ISSUE A CREDIT OR SEND A NERVE STIMULATOR / LOCATOR FOR ANY AFFECTED PRODUCT RETURNED. WHEN YOU SEND THE AFFECTED PRODUCT, CLEARLY IDENTIFY THE EXPORT PACKAGING PARTY ON THE OUTSIDE OF THE SHIPPING PACKAGE, THE PRODUCT RETURN AUTHORIZATION NUMBER SPECIFIED IN THE NOTIFICATION LETTER AND INCLUDE A COPY OF THE CORRESPONDENCE DATE OF JUNE 19, 2000 AND THE CHECKLIST FOR RECEIPT OF THE CREDIT. FILL IN THE CHECKLIST AND FAX FOR MEDTRONIC XOMED SURGICAL PRODUCTS 1 (904) 296-2386. FOR FURTHER INFORMATION, PLEASE CONTACT YOUR LOCAL REPRESENTATIVE OR DIRECTLY WITH MEDTRONIC XOMED SURGICAL PRODUCTS CONSUMER SERVICE BY PHONE 1 (904) 296-9600 IN THE UNITED STATES.

Device

STIMULATOR / NERVE LOCATOR, DISPOSABLE PULSATRON LL; IDENTIFIER: NO. CATALOG 82-62015;

Manufacturer

MEDTRONIC XOMED SURGICAL PRODUCTS INC DIV MEDTRONIC INC
  • Source
    ANVSANVISA