BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2191256 · Received July 19, 2011

    Report

    Report Number
    2024601-2011-00597
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNKNOWN. (B)(4). THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS AS WELL AS TO INDICATE THE PRODUCT SERIAL NUMBER, THE DATE OF THE EVENT, AND THE IMPLANT AND EXPLANT DATES. THE INFORMATION HAS NOT YET BEEN RECEIVED BY ALLERGAN. THE CONNECTOR TYPE CANNOT BE IDENTIFIED NOR AN ASSUMPTION BE MADE AS TO THE TYPE OF CONNECTOR ASSOCIATED WITH THIS COMPLAINT BECAUSE NO SERIAL NUMBER OR IMPLANT DATE WAS GIVEN. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF LEAKAGE AS FOLLOWS: "DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BAND, THE PORT OR THE CONNECTOR TUBING. CAUTION: FAILURE TO CREATE A STABLE, SMOOTH PATH FOR THE ACCESS PORT TUBING, WITHOUT SHARP TURNS OR BENDS, CAN RESULT IN TUBING BREAKS AND LEAKAGE. CARE MUST BE TAKEN DURING BAND ADJUSTMENT TO AVOID PUNCTURING THE TUBING WHICH CONNECTS THE ACCESS PORT AND BAND, AS THIS WILL CAUSE LEAKAGE AND DEFLATION OF THE INFLATABLE SECTION." DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF A DAMAGED DEVICE: "CAUTION: THE BAND, ACCESS PORT AND CALIBRATION TUBE MAY BE DAMAGED BY SHARP OBJECTS AND MANIPULATION WITH INSTRUMENTS. A DAMAGED DEVICE MUST NOT BE IMPLANTED. FOR THIS REASON, A STAND-BY DEVICE SHOULD BE AVAILABLE AT THE TIME OF SURGERY."

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED ALLEGED "FAILED EQUIPMENT." ALLERGAN IS CURRENTLY AWAITING FOLLOW-UP INFORMATION AND A VOLUNTARY MEDWATCH REPORT FROM THE RISK MANAGEMENT DEPARTMENT AT THE MEDICAL CENTER. THE DEVICE RETURN IS PENDING AT THIS TIME. THE REPORTER NOTED THAT IT IS POLICY OF THE HOSPITAL TO RETAIN THE EXPLANTED MEDICAL DEVICES AT THE HOSPITAL, THEREFORE, THE DEVICE WILL PROBABLY NOT BE RETURNED TO ALLERGAN FOR PRODUCT ANALYSIS. ALL ADDITIONAL AVAILABLE INFORMATION WILL BE FORWARDED TO ALLERGAN IN A COPY OF THE COMPLETED VOLUNTARY MEDWATCH REPORT, PER THE REPORTER.

    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