BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK-SIZE)

    MDR report key: 2739763 · Received September 7, 2012

    Report

    Report Number
    2024601-2012-00806
    Event Type
    Malfunction
    Date Received
    September 7, 2012
    Date of Event
    August 8, 2012
    Report Date
    August 8, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNK. MEDWATCH SENT TO FDA ON: (B)(4) 2012. FOLLOW-UP WITH THE AUTHORS OF THE ABSTRACT IS NOT POSSIBLE SINCE NO CONTACT INFO WAS PROVIDED; THEREFORE, WE WERE UNABLE TO REQUEST RETURN OF THE DEVICE. THE CONNECTOR TYPE CANNOT BE IDENTIFIED, NOR AN ASSUMPTION MADE AS TO THE TYPE OF CONNECTOR ASSOCIATED WITH THIS COMPLAINT, BECAUSE NO SERIAL NUMBER OR IMPLANT DATE WAS GIVEN. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE NO ANALYSIS OF TESTING HAS BEEN DONE. DEVICE LABELING ADDRESSES THE EVENT OF LEAK AS FOLLOWS: "DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BAND, THE PORT, OR THE CONNECTOR TUBING."

    Description of Event or Problem · 1

    ABSTRACT RECEIVED FROM ALLERGAN (B)(4), GLOBAL LITERATURE AND INFO SERVICES, THROUGH SPECIAL "PRODUCT WATCH"; OBES SURG (2012) 22:1144-1205 O-028, "RESULTS OF TREATMENT OF MORBID OBESITY IN A HIGH VOLUME CENTER", (B)(6). ABSTRACT MENTIONED: "IN PTS PRESENTED WITH FAILED PRIMARY SURGERY, CONVERSION FROM LAPAROSCOPIC GASTRIC BANDING TO GASTRIC BYPASS WAS MOSTLY PERFORMED. MAJOR COMPLICATIONS AS LEAKAGE IS (B)(6) FOR THE ENTIRE GROUP AND (B)(6) FOR REVISIONAL PROCEDURES. MORTALITY WAS NIL." ALTHOUGH THE MANUFACTURER OF THE DEVICE IS UNK, IT IS ALLERGAN'S APPROACH TO COMPLIANCE TO RESOLVE ALL DOUBT IN FAVOR OF REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK-SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI