BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESIST-A-BAND

    MDR report key: 8286555 · Received January 29, 2019

    Report

    Report Number
    2435946-2019-00001
    Event Type
    Injury
    Date Received
    January 29, 2019
    Date of Event
    March 15, 2018
    Report Date
    January 10, 2019
    Manufacturer
    QUALITY LATEX PRODUCT LTD (PVT)
    Product Code
    IOD
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    PERSON WAS USING THE RESIST-A-BAND DURINGNA GROUP EXERCISE CLASS (BARRE-FUSION) AT SPORTS CLUB. THE BAND BROKE AND THE PERSON FELL AND BROKE HER WRIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77648 RESIST-A-BAND RESISTANCE BAND IOD QUALITY LATEX PRODUCT LTD (PVT) LXB5873R UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention