BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAPISEAL PATCH

    MDR report key: 132066 · Received November 11, 1997

    Report

    Report Number
    2952600-1997-00001
    Event Type
    Injury
    Date Received
    November 11, 1997
    Date of Event
    October 9, 1997
    Report Date
    November 7, 1997
    Manufacturer
    FUSION MEDICAL TECHNOLOGIES, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAD SEGMENTECTOMY FOR RECURRENCE OF LUNG CANCER. (THIS WAS HER SECOND LUNG SURGERY). THE SURGEON APPLIED A RAPISEAL PATCH TO AN AIR LEAK ON A ROUGH SURFACE. INTRA-OPERATIVELY THE RAPISEAL PATCH SEALED THE SMALL LEAK. HOWEVER, THE PT WAS LEAKING AT DAY ONE FOLLOWING SURGERY AND THE LEAK GOT WORSE. SHE WAS SENT HOME WITH A HEIMLICH VALVE. SHE CAME IN FOR A FOLLOW-UP AND WAS STILL LEAKING AIR. THE SURGEON DECIDED TO REOPERATE, BECAUSE SHE HAD A LARGE SPACE AS WELL. IN THE RE-OPERATION (WHICH OCCURRED SEVERAL WEEKS AFTER THE ORIGINAL SURGERY), THE PATCH WAS STILL ATTACHED, BUT AIR WAS LEAKING THROUGH IT AND THE PATCHED TISSUE AND THAT SURROUNDING IT HAS "NECROSED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPISEAL PATCH Implant ABSORBABLE GELATIN PATCH FTL FUSION MEDICAL TECHNOLOGIES, INC. 4FG102-4 97-0605

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R 3. SILVER BULLET ELECTRODE.| 2. HEIMLICH VALVE,| 1. CHEST TUBES,