BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2820251 · Received October 31, 2012

    Report

    Report Number
    2024601-2012-01121
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 2, 2012
    Report Date
    October 3, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNKNOWN. MEDWATCH SENT TO FDA ON: (B)(4) 2012. ALLERGAN HAS RECEIVED THE PRODUCT; HOWEVER, A PIECE OF TUBING WAS RETURNED. THE REPORTER OF THE COMPLAINT WAS ASKED TO INDICATE THE PRODUCT MODEL NUMBER, SERIAL NUMBER, DATE OF EVENT, IMPLANT DATE AND PATIENT DATA. THE INFORMATION HAS NOT YET BEEN RECEIVED BY ALLERGAN. ALLERGAN HAS RECEIVED THE PRODUCT; HOWEVER, THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. FURTHER INFORMATION FROM THE REPORTER REGARDING THE MODEL NUMBER, SERIAL NUMBER, THE EVENT DATE, IMPLANT DATE, DIAGNOSTIC TESTING AND PATIENT DATA HAS BEEN REQUESTED. 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."

    Description of Event or Problem · 1

    PHYSICIAN REPORTED: THE BAND HAS BROKEN AT THE "METAL CONNECTION POINT" OR STAINLESS STEEL CONNECTOR.

    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