BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEPITEL

    MDR report key: 1884097 · Received October 21, 2010

    Report

    Report Number
    3004763499-2010-00004
    Event Type
    Injury
    Date Received
    October 21, 2010
    Date of Event
    September 22, 2010
    Report Date
    October 21, 2010
    Manufacturer
    MOLNLYCKE HEALTH CARE
    Product Code
    MGP
    PMA / PMN Number
    K984371
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO REVIEW OF THE DEVICE HISTORY RECORD COULD BE CONDUCTED AS NO LOT NUMBER OR SAMPLE WAS PROVIDED.

    Description of Event or Problem · 1

    CLINICIAN STATED (3) 3"X4" PIECES OF MEPITEL WERE PLACED ONTO A FEMALE PATIENT'S BOWEL UNDERNEATH A KCI WOUND VAC (2 VERTICAL AND 1 HORIZONTAL). THE PATIENT HAD NO FASCIA ON THE BOWEL, ACCORDING TO THE CLINICIAN. THE V.A.C. HAD ONLY BEEN ON FOR 3 HOURS AND THE PATIENT STARTED TO EVISCERATE UNDERNEATH THE V.A.C. THEY REMOVED THE V.A.C. AND THEN PULLED OFF THE PIECES OF MEPITEL. TWO PIECES OF MEPITEL WAS STICKING ONTO THE BOWEL. THEY USED SALINE SOLUTION TO TRY TO GET THE STUCK PIECE OF MEPITEL OFF THE BOWEL. WHEN THAT DID NOT WORK, THEY HAD TO REMOVE 3RD ONE IN OPERATING ROOM. IN THE OPERATING ROOM, THEY HAD PERFORATED A HOLE IN THE BOWEL ABOUT 1 CM X 1 CM WHILE TRYING TO GET THE MEPITEL OFF THE BOWEL. OPERATING ROOM HAD PATCHED THE HOLE ON BOWEL. THE CLINICIAN WAS CONTACTED TO CHECK ON THE PATIENT, SHE STATED THE PATIENT IS DOING MUCH BETTER SINCE THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEPITEL MEPITEL MGP MOLNLYCKE HEALTH CARE NOT KNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other