BEUDAMED
    FDA Adverse Event Other Summary report: N

    400ML RESERVOIR W/TROCAR 1/8" 10FR DRAIN

    MDR report key: 53480 · Received December 4, 1996

    Report

    Report Number
    1416557-1996-00011
    Event Type
    Other
    Date Received
    December 4, 1996
    Date of Event
    November 11, 1996
    Report Date
    November 19, 1996
    Manufacturer
    MICROTEK MEDICAL, INC.
    Product Code
    GCY
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SUPERFICIALLY PLACED DRAIN IN RIGHT HIP BROKE DURING REMOVAL. PT RETURNED TO SURGERY FOR REMOVAL OF RETAINED DRAIN. APPEARED TO HAVE BEEN ENTRAPPED IN A SUTURE UPON REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 400ML RESERVOIR W/TROCAR 1/8" 10FR DRAIN Implant WOUND DRAINAGE KIT GCY MICROTEK MEDICAL, INC. SU130-402D UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other