BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    90043170 DERMACEA X-RAY 4X8 12 PLY STRL

    MDR report key: 5211595 · Received November 9, 2015

    Report

    Report Number
    1018120-2015-00031
    Event Type
    Malfunction
    Date Received
    November 9, 2015
    Report Date
    November 4, 2015
    Manufacturer
    ALLMED MEDICAL PRODUCTS
    Product Code
    NAB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 02/15/2016. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. TWO PHOTOGRAPHS WERE PROVIDED FOR EVALUATION. BASED ON THE ANALYSIS FROM THE PHOTS, IT LOOKS AS IF THE TEXTURE OF THE GAUZE WAS A TOO LOOSE. BASED ON THE INVESTIGATION AND ANALYSIS, THE POSSIBLE ROOT CAUSE WOULD BE RE-STERILIZATION OR OTHER TYPES OF PROCESSING PRIOR TO USE. THUS, NO CORRECTIVE ACTION OR PREVENTIVE ACTION IS PLANNED AT THIS TIME. THIS COMPLAINT WILL BE USED FOR TRENDING PURPOSE FOR FUTURE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 11/04/2015. AN INVESTIGATION IS CURRENTLY UNDER WAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2015 THAT A CUSTOMER HAD AN ISSUE WITH A GAUZE SPONGE. THE CUSTOMER STATES THAT ONE EACH WAS UNRAVELING WHEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742563 90043170 DERMACEA X-RAY 4X8 12 PLY STRL GAUZE SPONGE NAB ALLMED MEDICAL PRODUCTS 441602

    Patients

    Seq Age Sex Outcome Treatment
    1