BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE ADJ GASTRIC BAND-C

    MDR report key: 2895449 · Received January 3, 2013

    Report

    Report Number
    3005992282-2013-00001
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    July 9, 2012
    Report Date
    December 11, 2012
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION UNAVAILABLE. THE DEVICE WAS NOT RETURNED. ADDITIONAL INFORMATION PROVIDED: WHO DID THE IMPLANT? SURGEON- DR. (B)(6). DR. (B)(6) EXPLANTED THE BAND. NUMBER OF FILLS/ADJUSTMENT IF APPLICABLE? NEVER KEPT TRACK . APPROXIMATE VOLUME IN BAND IF APPLICABLE? HAD THE BAND UP TO 8 OR 9 CCS AT TIMES NOT ALL THE TIME, LOST 20-30 LBS. IN FIRST YEAR THEN GAINED BACK 10 LBS. WHO PERFORMED THE ADJUSTMENTS? CERTIFIED TECH DOES FILLS IN SURGEON'S OFFICE. TYPE OF PROBLEMS THE PATIENT IS EXPERIENCING? VOMITING, HOT SWEATY AND STOMACH WAS HURTING, HAPPENED A NUMBER TIMES IN A WEEK AND NOW HAS A HERNIA. ANY TESTS PERFORMED TO DIAGNOSE THE ISSUE? X-RAY WITH CONTRAST. HOW WAS THE PROBLEMS TREATED? SURGERY TO REMOVE . WHAT IS THE CURRENT STATUS OF THE PATIENT? THE PATIENT DOES NOT KNOW IF SHE STILL HAS THE HERNIA OR IF SURGEON FIXED IT. THE PATIENT REPORTS THAT SHE VOMITED SO HARD AFTER THE LAST FILL THAT A TOOTH FELL OUT.

    Additional Manufacturer Narrative · 1

    (B)(4); BUCKLE DAMAGED. THE STRAIGHT BAND WITH 7.5CM OF CATHETER, THE VELOCITY PORT WITH LOCKING CONNECTOR AND 15.5CM OF CATHETER AND THE TUBING STRAIN RELIEF WERE RETURNED. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE BALLOON WAS TORN, THIS TEAR IS 2CM IN LENGTH AND LOCALIZED AT 1CM FROM THE CATHETER CONNECTION, IT WAS ALSO NOTED THAT THE BUCKLE REINFORCING BAND WAS CUT ON ONE SIDE. IT IS LIKELY THAT THE DAMAGE TO THE BALLON AND THE REINFORCEMENT BAND BUCKLE OCCURRED DURING EXPLANT. VISUAL OR FUNCTIONAL ANALYSIS CANNOT CONFIRM EVENTS THAT ARE PHYSIOLOGICAL IN NATURE, SUCH AS A HERNIA.REGARDING TO THE INABILITY TO UNLOCKED THE BAND, A REVIEW OF THE PRODUCT INSTRUCTION FOR USE (IFU) WAS PERFORMED AND IT WAS NOTED THAT DETAILED INSTRUCTIONS ARE PROVIDED ON HOW TO UNLOCK THE BAND.A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND NO DISCREPANCIES WERE RECORDED DURING THE MANUFACTURING PROCESS IN RELATION TO THE ALLEGED ISSUE.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT POST OP AN ADJUSTABLE BAND PROCEDURE, SHE EXPERIENCED PROBLEMS WITH VOMITING AND AT TIMES VOMITED BLOOD. THE SURGEON RELEASED THE FLUID AND SENT THE PATIENT FOR X-RAYS AND FOUND A HERNIA. THE PATIENT REPORTS BEING ADMITTED FOR SURGERY ON AN UNKNOWN DATE. THE BUCKLE WAS NOT ABLE TO BE REMOVED SO THE SURGERY WAS ABORTED. AT A LATER DATE THE BAND WAS EXPLANTED. THE DEVICE IS IN PATHOLOGY AND THE ACCOUNT WILL NOT RELEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2095 REALIZE ADJ GASTRIC BAND-C IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention