Events

Alerte De Sécurité sur INTRASOUND UNITS BOOTS OF PAIN THERAPY; ALL UNITS 1999 AND 2000; THE FOLLOWING UNITS, MANUFACTURED IN 2001, ALREADY CORRUGATED HAVE LABELS WITH YELLOW OR RED ROUND STICKERS.

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 BOOTS THE CHEMISTS.

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
    63
  • Date
    2001-05-14
  • 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 medical devices agency (uk) is advising that the adapter box of the unit's outlet can break and explode without exploiting the unprotected wires as a potential to cause electrical shock to operators and users.
  • Action
    THE ENGLISH AGENCY RECOMMENDS: (1) IDENTIFY AND ISOLE ALL THESE PRODUCTS THAT WERE PURCHASED IN 1999 AND 2000 THAT MAY BE IN YOUR INVENTORY. (2) DISCONTINUE THE USE OF THE PRODUCTS AFFECTED IMMEDIATELY, TURN OFF THE ELECTRICITY SWITCH AND REMOVE THE ADAPTER FROM THE OUTLET. (3) RETURN THE PRODUCTS AFFECTED TO THE REPRESENTATIVE TO REPAIR, REPLACE OR REIMBURSEMENT. (4) REPORT USERS AND MAINTENANCE MANAGERS IN THE ESTABLISHMENT OF THE ALERT WITH THESE UNITS. HEALTH PROFESSIONALS WHO KNOW PATIENTS USING THESE EQUIPMENT MUST ALERT THEM FROM THE POTENTIAL PROBLEM AND GUIDE THEM TO TAKE THESE CORRECTIVE MEASURES.

Device

INTRASOUND UNITS BOOTS OF PAIN THERAPY; ALL UNITS 1999 AND 2000; THE FOLLOWING UNITS, MANUFACTURE...

Manufacturer

BOOTS THE CHEMISTS
  • Source
    ANVSANVISA