BEUDAMED
    FDA Adverse Event Other Summary report: N

    WOUND CLOSURE TRAY INCISION & DRAINAGE TRAY

    MDR report key: 199816 · Received November 24, 1998

    Report

    Report Number
    1933006-1998-00001
    Event Type
    Other
    Date Received
    November 24, 1998
    Date of Event
    September 24, 1998
    Report Date
    November 23, 1998
    Manufacturer
    NI-MED, INC.
    Product Code
    KDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER NOTIFIED NI-MED OF KITS IN THE FIELD THAT HAD HOLES IN THE BOTTOM OF THE TRAY FROM THE INSTRUMENTS. THE CAUSE OF THE INSTRUMENTS POKING THROUGH THE TRAY IS THE RESULT OF THE TRAY BEING MADE TOO DEEP DURING THE MFG PROCESS. BECAUSE THE TRAY WAS DEEPER, THE PLASTIC WAS TOO THIN, ALLOWING THE INSTRUMENTS TO CREATE HOLES. THE TRAY DEPTH WAS SET TOO DEEP BY MAINTENANCE PERSONNEL DURING THE MACHINE SET-UP. THE PERSONNEL INVOLVED WITH THIS HAVE BEEN RETRAINED AS A RESULT OF THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WOUND CLOSURE TRAY INCISION & DRAINAGE TRAY WOUND CLOSURE TRAY INCISION & DRAINAGE TRAY KDD NI-MED, INC. NA SEE ATTACHED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other