BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE ADJ GASTRIC BAND STR

    MDR report key: 1211153 · Received October 24, 2008

    Report

    Report Number
    3005992282-2008-00198
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    August 2, 2008
    Report Date
    October 20, 2008
    Manufacturer
    OBTECH MEDICAL SARL
    Product Code
    LTI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST OF A LAP GASTRIC BAND PROCEDURE, THE PATIENT WAS PRESENTED AT THE HOSPITAL WITH ABDOMINAL PAIN AND SWELLING. EXPERIENCED N/V, STAT UGI DONE WHICH WAS NEGATIVE FOR SLIPPAGE. FLUID REMOVED FROM BAND WITH IMMEDIATE IMPROVEMENT FOR SEVERAL DAYS. HOWEVER, PT. PRESENTED WITH SEVERE RIGHT MID ABDOMINAL PAIN WITH LOW GRADE FEVER OF 101. CT SCAN- POSSIBLE ABSCESS. REASON FOR EXPLANT: PERFORATION. IN 2008: REPEAT CT SHOWS SMALL PIECE OF TUBING IN ABDOMINAL CAVITY. ON 9/23/08: PT PRESENTS WITH RIGHT SIDED PAIN. ON THE FOLLOWING MONTH: SMALL PIECE OF TUBING WITH INFLAMMATION AROUND IT, WILL NEED TO BE REMOVED. THE PATIENT WAS SENT TO THE OR AND THE BAND HAD TO BE EXPLANTED. THE PATIENT REQUIRED AN ADDITIONAL HOSPITAL STAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REALIZE ADJ GASTRIC BAND STR LTI OBTECH MEDICAL SARL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention