BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDMOND DIAMOND KERRISON 4 OUP 7" 4M

    MDR report key: 399236 · Received June 10, 2002

    Report

    Report Number
    1121308-2002-00013
    Event Type
    Malfunction
    Date Received
    June 10, 2002
    Report Date
    June 10, 2002
    Manufacturer
    INTEGRA LIFESCIENCES CORP.
    Product Code
    HAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE STERILE PROCESS REP REPORTED NOTICING A SCREW MISSING FROM THE INSTRUMENT WHILE IN THE DECONTAMINATION ROOM. THE PT WHO UNDERWENT SURGERY WITH THE INSTRUMENT HAD AN X-RAY TO LOCATE THE SCREW BUT THE X-RAY WAS NEGATIVE. NO EVIDENCE WAS FOUND ON THE X-RAY THAT THE SCREW REMAINED IN THE PT. THE INSTRUMENT IS BEING RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REDMOND DIAMOND KERRISON 4 OUP 7" 4M NON-POWERED SURGICAL INSTRUMENT HAE INTEGRA LIFESCIENCES CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *