BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE ADJ GASTRIC BAND-C

    MDR report key: 1962217 · Received January 17, 2011

    Report

    Report Number
    3005992282-2011-00017
    Event Type
    Injury
    Date Received
    January 17, 2011
    Date of Event
    February 10, 2010
    Report Date
    January 3, 2011
    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

    (B)(4): INFORMATION UNAVAILABLE. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CONSUMER THAT POST IMPLANT A REALIZE ADJUSTABLE BAND, THE FIRST FILL AFTER THE SURGERY, THE SURGEON PLACED 4CCS AND THE PATIENT WAS UNABLE TO KEEP ANYTHING DOWN, SO YOU WENT BACK AND 2CCS WERE REMOVED. THE CONSUMER REPORT, STARTING ABOUT (B)(6) 2009, SHE WAS UNABLE TO KEEP FOOD DOWN. THE DOCTOR TOLD HER THAT EVERYTHING LOOKS FINE AND SHE KEPT FOLLOWING HER DIET, BUT WAS CONSTANTLY VOMITING. THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO DEHYDRATION. SHE WAS GIVEN IV FLUIDS AND STAYED IN THE HOSPITAL FOR FOUR DAYS. THE CONSUMER REPORTS THE SURGEON CAME AND EXAMINED HER AND ASKED HER IF SHE WANTED IT REMOVED AND SHE SAID, " YES, HOW CAN I LIVE LIKE THIS!" THE SURGEON DID NOT GIVE ANY EXPLANATION AS TO WHY SHE COULD NOT HOLD FOOD OR WATER DOWN. THE DEVICE WAS EXPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention