BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM VG

    MDR report key: 627227 · Received August 12, 2005

    Report

    Report Number
    2024601-2005-00491
    Event Type
    Injury
    Date Received
    August 12, 2005
    Date of Event
    July 14, 2005
    Report Date
    July 15, 2005
    Manufacturer
    *
    Product Code
    LTI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    FAMILY MEMBER REPORTED THE PT HAD A SLIPPED BAND AND A REVISION SURGERY WAS PERFORMED. NOW THE PT HAS PSEUDOMONAS AND THE BAND MAY HAVE TO BE REMOVED. FOLLOW UP FINDINGS WITH THE FAMILY MEMBER REPORTS "THE PT HAD THEIR PORT REMOVED AND IS BEING TREATED WITH THE ANTIBIOTIC LEVOQUIN ALONG WITH WET TO DRY DRESSING CHANGES". THIS IS THE SAME PT REPORTED UNDER MDR ID # 2024601-2005-00490 (INAMED COMPLAINT#2082919). THIS SECOND MDRI IS BEING SUBMITTED FOR THE SECOND MEDICAL DEVICE, ALSO A DEVICE MFG BY INAMED CORP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM VG DEVICE FOR TREATMENT OF MORBID OBESITY LTI * NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention