BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MASK, PROCEDURE, YELLOW

    MDR report key: 6086491 · Received November 8, 2016

    Report

    Report Number
    1423537-2016-00057
    Event Type
    Injury
    Date Received
    November 8, 2016
    Date of Event
    October 4, 2016
    Report Date
    December 1, 2016
    Manufacturer
    QUIROPRODUCTOS DE CUAUHTEMOC S. DE R.L. DE C.V.
    Product Code
    FXX
    UDI-DI
    10885380071997
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT WAS FORWARDED TO PLANT FOR INVESTIGATION. PLANT AWAITING SAMPLE RETURN. WILL FILE FOLLOW UP MEDWATCH REPORT ONCE PLANT RECEIVES AND EVALUATES SAMPLE.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BASED ON SAMPLE RECEIPT. THE LOT NUMBER WAS PROVIDED, THEREFORE THE DEVICE HISTORY RECORD WAS REVIEWED, AND  NO QUALITY ISSUES WERE REPORTED. (B)(4) SAMPLES WERE RECEIVED, AND WERE EVALUATED FOR DIMENSIONS, FOLDS, FOREIGN PARTICLES / FIBERS ON THE SURFACE. A SAMPLE MASK WAS WORN FOR 45 MINUTES, AND NO DEFECTS WERE OBSERVED. BASED OFF OF THE EVALUATION OF THE SAMPLES, THE ISSUE WAS NOT CONFIRMED. THERE IS NO CORRECTIVE ACTION AT THIS TIME, HOWEVER WE WILL CONTINUE TO MONITOR COMPLAINTS FOR SUCH ISSUES. ALL FINISHED GOODS ARE MADE FROM QUALIFIED MATERIAL THAT IS TESTED BEFORE USE. FINAL FINISHED PRODUCT MUST MEET PRODUCT SPECIFICATION AND PROCESS REQUIREMENTS BEFORE FINAL RELEASE TO SALABLE INVENTORY.

    Description of Event or Problem · 1

    HOME DIALYSIS PATIENT RECEIVED MASKS THAT HE SAYS ARE DUSTY/HAVE LOTS OF LINT AND MAKE HIM COUGH/SNEEZE/GET A SORE THROAT. HE SAW HIS FAMILY PHYSICIAN AND WAS DIAGNOSED WITH BRONCHITIS, WHICH HE STATES HIS PHYSICIAN SAID IS DUE TO THE MASKS. HE WAS PRESCRIBED ANTIBIOTICS. HE IS NOW USING A DIFFERENT MASK, APPARENTLY WITHOUT PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736018 MASK, PROCEDURE, YELLOW MASK, SURGICAL FXX QUIROPRODUCTOS DE CUAUHTEMOC S. DE R.L. DE C.V. 16CGH319 10885380071997

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other