BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDRT-TS (INTL) SINGLE 2X2

    MDR report key: 3818580 · Received April 2, 2014

    Report

    Report Number
    1121308-2014-00013
    Event Type
    Malfunction
    Date Received
    April 2, 2014
    Report Date
    March 12, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORP.
    Product Code
    MGR
    PMA / PMN Number
    P900033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 'DURING THE SURGERY WHEN THE PACKAGE WAS OPENED, CREASES WERE ADMITTED IN THE FIRST IDRT. ANOTHER IDRT WAS OPENED AND USED TO COMPLETE THE SURGERY.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199985 IDRT-TS (INTL) SINGLE 2X2 IDRT-TS MGR INTEGRA LIFESCIENCES CORP. 105NA0277860

    Patients

    Seq Age Sex Outcome Treatment
    1