BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOFRAGMENTABLE ANASTOMOSIS RING

    MDR report key: 23623 · Received July 7, 1995

    Report

    Report Number
    23623
    Event Type
    Injury
    Date Received
    July 7, 1995
    Date of Event
    June 25, 1995
    Report Date
    July 3, 1995
    Manufacturer
    DAVIS & GECK
    Product Code
    LNN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS ORIGINALLY ADMITTED WITH DIAGNOSIS OF DIVERTICULOSIS. SHE UNDERWENT SURGERY ON 6/14/95 WHERE THE BAR WAS IMPLANTED. SHORTLY AFTER HER HOSP DISCHARGE SOME 5 DAYS POST-OP SHE BEGAN TO COMPLAIN OF ABDOMINAL PAIN. SHE WAS READMITTED AND HAD A SECOND OPERATION ON 6/25/95 WHERE THE BAR WAS REMOVED AND NOTED TO BE FRAGMENTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOFRAGMENTABLE ANASTOMOSIS RING Implant RING LNN DAVIS & GECK 8090-00

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R