BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3042931 · Received April 4, 2013

    Report

    Report Number
    2134070-2013-00078
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Report Date
    March 14, 2013
    Manufacturer
    STERILMED, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR AS OF THE DATE OF THIS REPORT. A F/U REPORT WILL BE SENT IF THE DEVICE IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE LEAKED DURING A BARIATRIC SLEEVE PROCEDURE. THE DEVICE WAS DISCARDED. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139340 NA UNK GCJ STERILMED, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1