BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE ADJ GASTRIC BAND STR

    MDR report key: 1910143 · Received November 30, 2010

    Report

    Report Number
    3005992282-2010-00380
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    June 11, 2010
    Report Date
    November 5, 2010
    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 WAS NOT PROVIDED BY CONTACT. INFORMATION UNAVAILABLE. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    CONSUMER REPORTS EXPERIENCING PAIN AND VOMITING ONE-YEAR POST IMPLANT OF A REALIZE ADJUSTABLE BAND. THE LOST 15 LBS AT A MAXIMUM LOSS. THE PATIENT ALSO REPORTED HAVING STOMACH CRAMPING AND GALL BLADDER ISSUES. AFTER ABOUT FORTY-FIVE MINUTES TO AN HOUR AFTER EATING THE PATIENT WOULD START GETTING SICK AFTER EVERY MEAL. THE PATIENT EVEN STARTED THE EATING PROGRAM ALL OVER AGAIN AND THAT DID NOT WORK. PER THE CONSUMER, THE SURGEON MENTIONED THAT THE TISSUE AROUND THE BAND WAS INFLAMED WHEN IT WAS REMOVED. THE PATIENT'S GALL BLADDER WAS REMOVED AT THE TIME OF THE BAND AND PORT REMOVAL AS THERE WAS LOTS OF BILE PRESENT. CONSUMER REPORTS FEELING GOOD BUT SOMETIMES HAVE PAIN BY GALLBLADDER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention