BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPOUCH RETRIEVAL BAG

    MDR report key: 250386 · Received November 16, 1999

    Report

    Report Number
    2210968-1999-00550
    Event Type
    Malfunction
    Date Received
    November 16, 1999
    Date of Event
    October 13, 1999
    Report Date
    November 1, 1999
    Manufacturer
    ETHOX CORP
    Product Code
    MDM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC HERNIA PROCEDURE THE METAL RIM "SPLINTERED". THE SURGEON PULLED THE SUTURE AND THE METAL RIMS "SPLINTERED". THE METAL RIM WAS RETRIEVED FROM THE PT. THERE WERE NO PT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPOUCH RETRIEVAL BAG MANUAL SURG. INTR. (ENDOSCOPE) MDM ETHOX CORP NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN