BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYS (STANDARD)

    MDR report key: 3834612 · Received May 2, 2014

    Report

    Report Number
    2024601-2014-00243
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    May 17, 2013
    Report Date
    April 9, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. ALLERGAN HAS RECEIVED THE PRODUCT. HOWEVER, THE DEVICE HAS NOT BEEN IDENTIFIED NOR HAS THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. BASED UPON THE MODEL NUMBER PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN HAS RECEIVED THE PRODUCT. HOWEVER, THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. FURTHER INFO FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PT DETAILS HAS BEEN REQUESTED. NO ADD'L INFO IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    ALLERGAN'S DEVICE ANALYSIS LAB RECEIVED A LAP-BAND SYS. PAPERWORK RECEIVED BY THE LAB INDICATES THE LAP-BAND SYS WAS REMOVED DUE TO "PELVIC PAIN." PAPERWORK ALSO INDICATED THERE WAS A PRE-OPERATIVE PROBLEM OF "GASTRIC OBSTRUCTION." IT IS NOT KNOWN IF THE DEVICE HAS BEEN REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264057 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYS (STANDARD) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention