BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMASORB 5MM LAPAROSCOPIC 38 CM

    MDR report key: 1152043 · Received August 12, 2008

    Report

    Report Number
    1152043
    Event Type
    Malfunction
    Date Received
    August 12, 2008
    Date of Event
    March 8, 2008
    Report Date
    August 12, 2008
    Manufacturer
    DAVOL INC.
    Product Code
    MAI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC TAPP INGUINAL HERNIA REPAIR, THE SURGEON USED A PERMASORB ABSORBABLE FASTENER TO ATTACH MESH. THE CORK SCREW FASTENERS WOULD NOT STAY IN, AND WOULD NOT STAY FASTENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMASORB 5MM LAPAROSCOPIC 38 CM FASTENER, ABSORBABLE MAI DAVOL INC. 0113092 CVRL0004

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR