BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OR TOWELS, WHITE 2/PK, PREWASHED

    MDR report key: 3983134 · Received June 30, 2014

    Report

    Report Number
    1060680-2014-00029
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    May 14, 2014
    Report Date
    June 26, 2014
    Manufacturer
    DEROYAL INDUSTRIES
    Product Code
    KKX
    PMA / PMN Number
    K001858
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE QFI REPORT WAS REVIEWED TO OBTAIN THE SALES AND SIMILAR COMPLAINT INFO. DEROYAL HAS SOLD (B)(4) CASES OF THE FINISHED GOOD FROM 2012 TO 2014. THERE HAVE BEEN NO PREVIOUS REPORTS OF THIS NATURE FOR THE FINISHED GOOD. THE SAMPLE WAS RECEIVED AND EVALUATED BY THE QC COMPLAINT SPECIALIST. THE WRAP WAS VISIBLE WITHIN THE SEAL AREA OF THE PRODUCT WHICH COULD HAVE BEEN A CONTRIBUTING FACTOR TO THE REPORT. IT HAS BEEN REQUESTED THAT THE VENDOR IDENTIFY IF THE WRAP IS PRESENT ON THE DEVICE DURING THE GAMMA PROCESS. A SCAR HAS BEEN ISSUED TO (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TOWEL WRAP WAS DAMAGED. THE RN NOTED INNER BLUE PACKING APPEARED TO BE TORN IN SEVERAL LOCATIONS INSIDE STERILE OUTER PACKAGING. THERE WAS NO REPORT OF INJURY, BUT THE PRODUCT DAMAGE WAS NOTICED BY THE RN WHEN PRODUCT WAS STILL INSIDE THE STERILE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381354 OR TOWELS, WHITE 2/PK, PREWASHED DRAPE, SURGICAL KKX DEROYAL INDUSTRIES 111130

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention