BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARIATRIC RING MARKER

    MDR report key: 7130346 · Received December 19, 2017

    Report

    Report Number
    1522875-2017-00001
    Event Type
    Injury
    Date Received
    December 19, 2017
    Report Date
    December 19, 2017
    Manufacturer
    KAPP SURGICAL INSTRUMENT, INC
    Product Code
    NEU
    PMA / PMN Number
    K072216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2017 KAPP SURGICAL RECEIVED AN EMAIL FROM (B)(6)WITH THE FOLLOWING TEXT : "SUBJ: BARIATRIC RING MARKER K9536. WHAT IS IT MADE OF? MINE BROKE INSIDE OF ME AND THEY HAD TO REMOVE PART OF MY STOMACH AND INTESTINES DIE TO THE DAMAGE IT CAUSED. CALL ME PLEASE THANKS (PHONE NUMBER)" REPRESENTATIVES FROM KAPP HAVE ATTEMPTED TO COLLECT ADITIONAL INFORMATION INCLUDING MODEL NUMBER, LOT NUMBER, AND ADDITIONAL DETAILS REGARDING THE ALLEGED INCIDENT. THE LAST ATTEMPT WAS MADE (B)(6) 2017. SO FAR (B)(6) HAS ONLY STATED THAT SHE WAS COLLECTING MEDICAL RECORDS AND PERSURING LEGAL ACTION. NO OTHER INFORMATION HAS BEEN PROVIDED. THIS REPORT IS LATE BECAUSE OF DIFFICULTY SETTING UP THE EMDR PROCESS ON OUR COMPUTER SYSTEM.

    Description of Event or Problem · 1

    IN AN EMAIL DATED (B)(6) 2017 FROM (B)(6), IT WAS REPORTED "MINE BROKE INSIDE OF ME AND THEY HAD TO REMOVE PART OF MY STOMACH AND INTESTINES DUE TO THE DAMAGE IT CAUSED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909308 BARIATRIC RING MARKER MARKER RING NEU KAPP SURGICAL INSTRUMENT, INC K9536 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S