BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KC500 48 X 48 WRAP, 500 STRAND

    MDR report key: 3987011 · Received August 4, 2014

    Report

    Report Number
    MW5037653
    Event Type
    Injury
    Date Received
    August 4, 2014
    Date of Event
    July 31, 2014
    Report Date
    August 1, 2014
    Manufacturer
    KIMBERLY CLARK
    Product Code
    FRG
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WE USE KIMBERLY-CLARK KIMGUARD ONE-STEP STERILIZATION WRAP, KC500, 48" X 48", 24/CS MODEL: 62148 TO WRAP OUR TRAYS IN CENTRAL PROCESSING FOR SURGERY AND IT HAS HAD HOLES IN IT. >50 TIMES IN THE LAST 3 MONTHS WER HAVE FOUND HOLES NOT CAUSED BY OUR STERILIZATION PROCESS, IT IS HAPPENING AT THE MANUFACTURER. DATES FOR USE: (B)(6) 2014 - (B)(6) 2014. DIAGNOSIS OR REASON FOR USE: COVER STERILIZED INSTRUMENTS FOR SURGICAL PROCESSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455060 KC500 48 X 48 WRAP, 500 STRAND STERILIZATION WRAP FRG KIMBERLY CLARK KC500 121X21CMLT4180

    Patients

    Seq Age Sex Outcome Treatment
    1 Other