BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLENDERTONE ABS

    MDR report key: 5382718 · Received January 21, 2016

    Report

    Report Number
    8020867-2015-00011
    Event Type
    Injury
    Date Received
    January 21, 2016
    Date of Event
    October 31, 2011
    Report Date
    December 5, 2011
    Manufacturer
    BIO-MEDICAL RESEARCH LTD
    Product Code
    NGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO MEDICAL REPORT OR MEDICAL HISTORY OF THE USER WAS PROVIDED TO THE INVESTIGATION. NO CAUSAL LINK BETWEEN THE USER AND THE DEVICE CAN BE ESTABLISHED. THIS COMPLAINT HAS BEEN REPORTED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINTS REPRESENTING EVENTS THAT ARE MDR REPORTABLE. THE DATE OF EVENT PROVIDED IS A BEST ESTIMATE BY THE MANUFACTURER BASED ON INFORMATION RECEIVED.

    Description of Event or Problem · 1

    BIO-MEDICAL RESEARCH LTD. WAS NOTIFIED BY IT'S DISTRIBUTOR OF A COMPLAINT REGARDING THE SYSTEM ABS (MODEL AND SERIAL NUMBER UNKNOWN). THE CUSTOMER PURCHASED THE DEVICE IN (B)(6) 2011 AND HAD USED IT FOR APPROXIMATELY 10 TIMES, AT 30-60 MINUTES PER SESSION. THE CUSTOMER HAS STATED THAT THE DEVICE FELT UNCOMFORTABLE AROUND THE END OF (B)(6) OF THE SAME YEAR AND HAD CONSULTED WITH THEIR PHYSICIAN. THE CUSTOMER WAS SUBSEQUENTLY DIAGNOSED WITH A BROKEN RIB AND REQUIRED HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41993 SLENDERTONE ABS POWERED MUSCLE STIMULATOR NGX BIO-MEDICAL RESEARCH LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization