BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMASHIELD KNITTED DOUBLE VELOUR FABRIC

    MDR report key: 78109 · Received March 21, 1997

    Report

    Report Number
    2242352-1997-00024
    Event Type
    Injury
    Date Received
    March 21, 1997
    Date of Event
    November 19, 1996
    Report Date
    February 25, 1997
    Manufacturer
    MEADOX MEDICAL, INC., DIV. B.S.C.
    Product Code
    DXZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED, UNUSED PRODUCTS FROM THIS LOT WERE EVALUATED AND FOUND TO BE WITHIN SPECIFICATION FOR POROSITY. SINCE THE ACTUAL PRODUCT INVOLVED IN THE INCIDENT COULD NOT BE RETURNED FOR EVALUATION, THE EXACT CAUSE OF THE DR.'S EXPERIENCE IS UNK. CODE 86: THE MFG BATCH RECORDS FOR THE DEVICE WERE REVIEWED. CODE 100: THE BATCH RECORDS WERE NOT ATYPICAL - NO SIMILAR INCIDENTS AGAINST THIS BATCH.

    Description of Event or Problem · 1

    PATCH LEAKED BLOOD FOR APPROX TWENTY MINUTES. QUANTITY OF BLOOD IS UNKNOWN. LEAKAGE WAS STOPPED WITH AVITENE, HEMOSTATIC AGENT AND PRESSURE. THE PT'S CONDITION, POST-OPERATIVELY WAS INITIALLY STABLE, BUT AFTERWARD PT DEVELOPED A HEMOTOMA. LATER, WHEN GIVEN HEPARIN, EVACUATION WAS REQUIRED. THIS IS ALL INFO REPORTED TO CO BY THE DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMASHIELD KNITTED DOUBLE VELOUR FABRIC Implant CARDIOVASCULAR FABRIC DXZ MEADOX MEDICAL, INC., DIV. B.S.C. 019508 116029

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other