Events

Safety Alert for RECLINABLE ELECTRIC CHAIRS

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by N/A.

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
    174
  • Date
    2000-11-03
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    The united kingdom medical devices agency has delivered a safety information informing hospitals that there is the risk of children become prematured and machined in the mechanism of reclining electric chairs.
  • Action
    MDA DECLARES THAT ALL PERSONNEL INVOLVED IN THE SUPPLY OF CHAIRS SHOULD ALERT USERS AND ATTENDEES ABOUT THE POTENTIAL RISK OF A CHILD ABUSE AND MACHINING. MDA RECOMMENDS THE FOLLOWING: (1) FOLLOW THE MANUFACTURER'S INSTRUCTIONS (2) MAKE SURE THE CHILDREN ARE SUPERVISED WHEN THEY ARE CLOSE TO THE ABOVE CHAIRS. (3) NEVER ALLOW CHILDREN TO PLAY WITH THE CHAIRS OR THE CONTROLS (4) DISCONNECT THE OUTLET OR REMOVE THE KEY, IF ANY, WHEN THE CHAIR IS NOT IN USE. (5) REPORTING VISITORS AND CHILDREN ON THE POTENTIAL RISK OF AGGRESSES. FOR FURTHER INFORMATION, CONTACT YOUR LOCAL SUPPLIER REPRESENTATIVE OR DIRECTLY WITH RAY HODGKINSON OR SARAH LEPAK AT THE BRITISH HEALTHCARE TRADES ASSOCIATION BY PHONE 44 (173) 245 8868. CONSULTATIONS TO MDA MUST MENTION REFERENCE NUMBER 20000605.011-22 E BE ADDRESSED TO MALCOLM ROE OR RICHARD GLOVER BY CORRESPONDENCE SUBMITTED TO HANNIBAL HOUSE, ELEPHANT AND CASTLE, LONDON SE1 6TQ, ENGLAND; BY PHONE (0207) 972 8164 OR 8245; OR FAX (0207) 972 8106.

Device

RECLINABLE ELECTRIC CHAIRS
  • Model / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA