BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CASSETTES FOR LPC FINEMESH PINK/1440

    MDR report key: 3020586 · Received March 21, 2013

    Report

    Report Number
    8010478-2013-00001
    Event Type
    Injury
    Date Received
    March 21, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 12, 2013
    Manufacturer
    LEICA MICROSYSTEMS NUSSLOCH GMBH
    Product Code
    IEO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION OF THE EVENT IS CURRENTLY UNDERWAY AND IT WILL BE SUBMITTED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT DURING PROCESSING THE TISSUE WAS LOST. THE CATCH ON THE CASSETTE WAS BROKEN. AS A RESULT ONE FEMALE PT REQUIRED A REBIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117176 CASSETTES FOR LPC FINEMESH PINK/1440 NONE IEO LEICA MICROSYSTEMS NUSSLOCH GMBH 14060546850 1034710204

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR