BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILAGEN ABDOMINAL STRIP

    MDR report key: 9653832 · Received January 30, 2020

    Report

    Report Number
    MW5092668
    Event Type
    Injury
    Date Received
    January 30, 2020
    Date of Event
    January 16, 2020
    Report Date
    January 28, 2020
    Manufacturer
    NEWMEDICAL TECHNOLOGY, INC.
    Product Code
    MDA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE SILAGEN TAPE CAUSED A REACTION ON MY SKIN AND THE INCISION BEGAN OOZING AND THE SKIN WAS PEELING OFF. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112749 SILAGEN ABDOMINAL STRIP ELASTOMER, SILICONE, FOR SCAR MANAGEMENT MDA NEWMEDICAL TECHNOLOGY, INC. ABDOMINAL STRIP

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR