BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAXI PANNICULUS RETRACTOR

    MDR report key: 14211263 · Received April 26, 2022

    Report

    Report Number
    1722684-2022-00002
    Event Type
    Injury
    Date Received
    April 26, 2022
    Date of Event
    April 1, 2022
    Report Date
    April 19, 2022
    Manufacturer
    CLINICAL INNOVATIONS LLC.
    Product Code
    HDL
    UDI-DI
    00814247020345
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    "PATIENT EXPERIENCED TWO SMALL AREAS OF SKIN BREAKDOWN AND DISCOMFORT UPON REMOVAL OF TRAXI. PEELING SKIN AND BURNING IN THOSE AREAS WHEN SHOWERING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1539646 TRAXI PANNICULUS RETRACTOR TRAXI HDL CLINICAL INNOVATIONS LLC. PRS-1030 M44919 00814247020345

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown