BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 1583496 · Received January 20, 2010

    Report

    Report Number
    2024601-2010-00048
    Event Type
    Injury
    Date Received
    January 20, 2010
    Date of Event
    April 15, 2007
    Report Date
    December 22, 2009
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. THE PRODUCT ASSOCIATED WITH THIS REPORT WILL NOT BE RETURNED. BASED UPON THE DATE SPAN OF THE STUDY PROVIDED BY THE RPTR, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. BAND SLIPPAGE AND REFLUX ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING ADDRESSES THE REPORTED EVENTS OF BAND SLIPPAGE AND REFLUX AS FOLLOWS: "BAND SLIPPAGE AND/OR POUCH DILATATION CAN OCCUR". "OVER-DISSECTION OF THE STOMACH DURING PLACEMENT MAY RESULT IN SLIPPAGE OR EROSION OF THE BAND AND REQUIRE REOPERATION". "GASTROESOPHAGEAL REFLUX, NAUSEA AND/OR VOMITING WITH EARLY OR MINOR SLIPPAGE MAY BE SUCCESSFULLY RESOLVED BY BAND DEFLATION IN SOME CASES. MORE SERIOUS SLIPPAGES MAY REQUIRE BAND REPOSITIONING AND/OR REMOVAL".

    Description of Event or Problem · 1

    DOCTOR REPORTED EVENT OF "BAND SLIPPAGE" AND "GASTROESOPHAGEAL REFLUX" FROM JOURNAL ARTICLE: "SAFETY AND SHORT-TERM OUTCOMES OF LAPAROSCOPIC SLEEVE GASTRECTOMY AS A REVISIONAL APPROACH FOR FAILED LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING IN THE TREATMENT OF MORBID OBESITY", OBES SURG (2009) 19, 1612-1616, DOI 10.1007/S11695-009-9941-4.

    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 Required Intervention