BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 1040183 · Received May 8, 2008

    Report

    Report Number
    3005992282-2008-00066
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 28, 2008
    Report Date
    April 11, 2008
    Manufacturer
    OBTECH MEDICAL SARL
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    D4; H4, 6: INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD A LAPAROSCOPIC ADJUSTABLE BAND PROCEDURE. TWO WEEKS POST OPERATIVELY, THE PT COMPLAINED OF STOMACH PAIN. THE PT CONTACTED THE SURGEON AND WAS ADMITTED TO HOSP AND THE BAND WAS REMOVED. THE BAND WAS NOT REPLACED. IT IS A POSSIBILITY THAT THE STOMACH WAS PERFORATED DURING IMPLANTATION. THE PT IS CURRENTLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE LTI OBTECH MEDICAL SARL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1