BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEN2 ADJUSTABLE GASTRIC BAND - 11 CM, UNLOCKA

    MDR report key: 3790850 · Received May 5, 2014

    Report

    Report Number
    3005992282-2014-00024
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 10, 2014
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS GASTRIC BAND WAS INITIALLY IMPLANTED ON THE (B)(6) 2008. SIX YEARS LATER THE BAND HAD TO BE REMOVED DUE TO EROSION WHICH OCCURRED AROUND ANTERIOR GREATER GASTRIC CURVE. REVISION OCCURRED ON (B)(6), 2014. NO PHOTOS OR X-RAY AVAILABLE. NO MEDICAL REPORTS OR OPERATIVE NOTES AVAILABLE. DEVICE HAS BEEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266401 GEN2 ADJUSTABLE GASTRIC BAND - 11 CM, UNLOCKA IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention