BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK DEVICE

    MDR report key: 184623 · Received August 27, 1998

    Report

    Report Number
    1527736-1998-02603
    Event Type
    Injury
    Date Received
    August 27, 1998
    Date of Event
    July 31, 1996
    Report Date
    July 27, 1998
    Manufacturer
    UNK
    Product Code
    GAG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    RECEIVED NOTIFICATION OF LAWSUIT. IT IS ALLEGED IN THE COMPLAINT THAT PLAINTIFF WAS ADMITTED FOR AN ABDOMINAL PERINEAL RESECTION AND REMOVAL OF RECTUM ON 07/21/1996. IT APPEARS FROM THE COMPLAINT, THE SURGEONS ATTEMPTED TO APPROXIMATE THE COLON TO THE RECTUM ON 3 SEPARATE OCCASIONS. THE THIRD ATTEMPT, RESULTED IN A PERFORATION AND TEAR OF THE VAGINA LED TO A RECTOVAGINAL FISTULA WHICH REQUIRED A SUBSEQUENT OPERATION FOR EMERGENCY COLOSTOMY ON JULY 31, 1996. 07/28/98 SPOKE WITH SALES REP WHO ADVISED DR. CONTACTED HER AFTER PROCEDURE WITH QUESTIONS RE: PROPER INSTRUMENT FIRING. THEY REVIEWED THE TECHNIQUE FOR FIRING INSTRUMENT AND CONCLUDED THE INSTRUMENT HAD FUNCTIONED NORMALLY. FOR THIS REASON, SHE DID NOT REPORT INCIDENT AS A PRODUCT INQUIRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK DEVICE UNK GAG UNK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention