BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE ADJ GASTRIC BAND STR

    MDR report key: 2223552 · Received August 25, 2011

    Report

    Report Number
    3005992282-2011-00185
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    May 23, 2010
    Report Date
    November 18, 2010
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE RETURNED DEVICE INDICATED THAT THE TUBING CONNECTION MET SPECIFICATION. THE REPORTED EVENT COULD NOT BE CONFIRMED. A DHR REVIEW WAS CONDUCTED AND NO DISCREPANCIES WERE OBSERVED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FLUID WAS UNABLE TO BE WITHDRAWN FROM THE REALIZE BAND. NO SIGN OF TUBING KINK OR DISCONNECT. SYSTEM INTACT, VERIFIED BY FLUOROSCOPY. ON (B)(6) 2010, A CT SCAN PERFORMED SHOWED BAND TUBING AND PORT DISCONNECT. SUBJECT INFORMED SURGEON AND HE PERFORMED ADJUSTMENT UNDER FLUOROSCOPY ON (B)(6) 2010. SURGEON INJECTED CONTRAST WHICH HE DID NOT SEE IT DISPERSE AND WAS UNABLE TO WITHDRAW. AT THAT TIME THE PATIENT ELECTED NOT TO HAVE PORT REPLACED FOR PERSONAL REASONS. THE PORT WAS REPLACED ON (B)(6) 2011. THE PATIENT HAS SINCE HAD VOLUME ADDED TO THE BAND SUCCESSFULLY.

    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