BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE ADJ GASTRIC BAND STR

    MDR report key: 2123420 · Received June 14, 2011

    Report

    Report Number
    3005992282-2011-00135
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    March 1, 2011
    Report Date
    May 19, 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 PATIENT THAT IN 2008 SHE HAD A REALIZE BAND PROCEDURE. IN (B)(6) 2011, SHE PRESENTED TO THE SURGEON'S OFFICE WITH ABDOMINAL PAIN. AN ENDOSCOPY WAS PERFORMED AND IT WAS DETERMINED THAT SHE HAD GASTRITIS. THE PATIENT WAS PRESCRIBED PEPCID AC AND REFERRED TO A GI PHYSICIAN. THE GI DOCTOR PRESCRIBED ACIPHEX. THE PATIENT HAD UP TO SIX FILLS, VOLUME IS UNKNOWN. IT IS AFTER THE LAST FILL THAT THE ABDOMINAL PAIN BEGAN. SHE STATED THAT SHE SAW NO RESULTS BECAUSE SHE LOST ONLY 10 POUNDS IN THREE YEARS. PER THE PATIENT, THE SURGEON STATED THE BAND WAS TOO TIGHT CAUSING THE ISSUE. THE BAND WAS REMOVED AT THE REQUEST OF THE PATIENT. THE PATIENT IS FINE.

    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 Required Intervention