BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHETIC LIMB

    MDR report key: 2021759 · Received March 12, 2011

    Report

    Report Number
    MW5019809
    Event Type
    Injury
    Date Received
    March 12, 2011
    Date of Event
    January 10, 1980
    Report Date
    March 12, 2011
    Product Code
    ISS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE PROBLEMS ARE THROUGHOUT THE (B)(6) ORTHOTIC AND PROSTHETIC CLINICS, AND CLINICS WITH FABRICATION AND MFG ATTACHED TO THEM. CUSTOM MADE BY CERTIFIED OR NON CERTIFIED LAB. NON COMPLIANCE IN MFG PREPARATION, DELIVERY, AND MATERIALS. ABC CERTIFIED LABS, AND ABC CERTIFIED CLINICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTHETIC LIMB ARTIFICIAL LIMB ISS CUSTOM MADE

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| O| R| S