BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE ADJ GASTRIC BAND STR

    MDR report key: 3833741 · Received May 27, 2014

    Report

    Report Number
    3005992282-2014-00027
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    April 25, 2009
    Report Date
    May 9, 2014
    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.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: COMPLAINT CANNOT BE CONFIRMED, EVALUATION OF THE DEVICE CANNOT CONFIRM EVENTS THAT ARE PHYSIOLOGICAL IN NATURE (I.E: PORT PAIN). INVESTIGATION HAS SHOWN THAT THE PORT IS FULLY FUNCTIONAL. BIOLOGICAL DEBRIS WAS INHIBITING FULL FUNCTIONALITY. THIS IS OUTLINED IN THE IFU STATING "TISSUE GROWTH MAY IMPEDE THE ABILITY TO ROTATE THE ACTUATOR RING AND RETRACT THE FASTENING HOOKS, SO THE PORT MAY REQUIRE DISSECTION FROM THE FASCIA FOR REMOVAL." A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED, AND NO DISCREPANCIES WERE RECORDED DURING THE MANUFACTURING PROCESS IN RELATION TO THE ALLEGED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUBJECT HAD BEEN COMPLAINING OF PORT PAIN SINCE (B)(6) 2013. IN (B)(6) 2014 THE PAIN GOT WORSE AND SHE REPORTEDLY CAME IN FOR THIS PROBLEM. AN ENDOSCOPY WAS PERFORMED TO RULE OUT BAND EROSION AND WAS NEGATIVE. HER PAIN WAS OF UNKNOWN ETIOLOGY BUT DUE TO EXTREME PAIN, THE DECISION WAS MADE TO REMOVE THE BAND SYSTEM. THE PAIN HAS BEEN RESOLVED SINCE REMOVAL. THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310111 REALIZE ADJ GASTRIC BAND STR IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other