BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFT CELL

    MDR report key: 362076 · Received November 16, 2001

    Report

    Report Number
    2083373-2001-00003
    Event Type
    Injury
    Date Received
    November 16, 2001
    Date of Event
    October 19, 2001
    Report Date
    November 15, 2001
    Manufacturer
    M-PACT CORPORATION
    Product Code
    HOZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    MD REPORTS THAT PT DEVELOPED "DLK" POST OPERATION; MAYBE CAUSED BY PVA SPEAR (SPONGE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52065 SOFT CELL PVA FOAM SPONGES HOZ M-PACT CORPORATION 0525 1220C

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other