BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED/SURG SHOE

    MDR report key: 90270 · Received May 8, 1997

    Report

    Report Number
    2020737-1997-00001
    Event Type
    Injury
    Date Received
    May 8, 1997
    Date of Event
    March 26, 1997
    Report Date
    May 8, 1997
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    IPG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SUBJECT PATIENT ALLEGEDLY FELL AFTER A STRAP TAB ON THE SUBJECT FOOT SUPPORT (79-81135) BROKE APART. DURING THE FALL, THE PATIENT HIT HER SUTURED WOUND AGAINST A HARD SURFACE, WHICH RESULTED IN THE RE-OPENING OF THE WOUND. SURGICAL INTERVENTION WAS REQUIRED TO TREAT THE RE-OPENED WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MED/SURG SHOE FOOT SUPPORT IPG SMITH & NEPHEW, INC. 79-81135 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention
    2