Events

Safety Alert for 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.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by DE ROYAL INDUSTRIES INC.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    14
  • Date
    2001-05-14
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    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