BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 10MM

    MDR report key: 1014041 · Received March 14, 2008

    Report

    Report Number
    2647580-2008-00146
    Event Type
    Malfunction
    Date Received
    March 14, 2008
    Report Date
    February 22, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GCJ
    PMA / PMN Number
    K924011
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP HERNIA REPAIR. ACCORDING TO THE REPORTER: A HOLE WAS FOUND ON THE BALLOON. REPORTER WAS NOT ABLE TO OBTAIN ANY OTHER ADD'L INFO. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACEMAKER BLUNT TIP TROCAR 10MM DISPOSABLE SURGICAL ACCESS DEVICE GCJ PONCE - USS P7H0356

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK