BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XX-SPAN DRESSING RETAINER

    MDR report key: 84834 · Received April 16, 1997

    Report

    Report Number
    1043612-1997-00001
    Event Type
    Injury
    Date Received
    April 16, 1997
    Date of Event
    November 18, 1996
    Report Date
    April 15, 1997
    Manufacturer
    HEALTH PRODUCTS DIV. ALBA-WALDNSIAN, INC.
    Product Code
    FQM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A MINOR SURGICAL EXCISION OF A CYST FROM THE THUMB OF THE PT WAS PERFORMED, A DRESSING WAS APPLIED TO THE SITE AND WAS RETAINED TO THUMB BY A DRESSING RETAINER. THE DR STATED THAT THE PT RETURNED APPROX THREE (3) DAYS LATER AND TAHT THE THUMB WAS NOTED TO BE BLACK IN COLOR. THE THUMB WAS AMPUTATED APPROX ONE WEEK AFTER THE ORIGINAL OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XX-SPAN DRESSING RETAINER TUBULAR ELASTIC DRESSING RETAINER FQM HEALTH PRODUCTS DIV. ALBA-WALDNSIAN, INC. XX-SPAN TUBULAR DRESSING RETAI UNK1

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention| S