Events

Safety Alert for 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.

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

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
    25
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    The medical devices agency (uk) is advising that the adapter box of the unit's outlet can break and feel completely, expose the deprotected wires as a potential to cause electric shock a.
  • 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