Events

Alerte De Sécurité sur CLAVICULAR SUPPORT ALLOYS: (1) SELF-ADJUSTABLE, (2) II; (3) NEOPRENE KNEE SUPPORT; (4) PUNISHED KNEE SKULL; (5) BANDS / LEATHER LINES OF TENNIS "; (6) AMBIDEXTROUS, UNIVERSAL PULSE; (7) UNIVERSAL PÉLVICAS DRIVE BELTS; (8) UNIVERSAL; (9) 15 CM; (10) ELASTIC ANCHOR SUPPORT BANDS 7.5 CM; (11) UNIVERSAL ABDOMINAL BAND OF 25 CM. ALL PRODUCT CODES MANUFACTURED FROM SEPTEMBER 30, 1998 TO 4 DECEMBER 2000.

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 DE ROYAL INDUSTRIES 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
    14
  • 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
    BRAZIL - 08/14/2001. THE KNEE SUPPORT OF NEOPRENE IS A NATIONAL MANUFACTURING PRODUCT, MADE BY THE COMPANY SALVAPÉ PRODUTOS ORTOPÉDICOS LTDA. IT ALSO INFORMES THAT IT IS NOT AN IMPORTED PRODUCT OF THE "ROYAL" COMPANY.
  • Cause
    Not declared correct composition of the products: there is natural rubber that had not been declared. the manufacturer began a correction by letter of december 12, 2000.
  • Action
    VERIFY THAT YOU HAVE RECEIVED THE DEROYAL LETTER OF DECEMBER 12, 2000. IDENTIFY AND ISOLE ALL THESE PRODUCTS THAT MAY BE IN YOUR INVENTORY. DEROYAL AFFIRMS THAT THE PRODUCTS MAY BE RETURNED FOR LABEL CORRECTION, OR USERS MAY REQUIRE THE NEW LABELS AND CORRESPOND IT ON THE PRODUCTS. FOR FURTHER INFORMATION CONTACT DEROYAL ON PHONE 0021-1-423-938-7828.

Device

CLAVICULAR SUPPORT ALLOYS: (1) SELF-ADJUSTABLE, (2) II; (3) NEOPRENE KNEE SUPPORT; (4) PUNISHED K...

Manufacturer

DE ROYAL INDUSTRIES INC
  • Source
    ANVSANVISA