BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUE COMFORT BOUFFANT 24 IN

    MDR report key: 7981447 · Received October 18, 2018

    Report

    Report Number
    1423537-2018-00243
    Event Type
    Injury
    Date Received
    October 18, 2018
    Date of Event
    September 12, 2018
    Report Date
    October 18, 2018
    Manufacturer
    HUBEI SAFEWAY PROTECTIVE PRODUCTS
    Product Code
    FYF
    UDI-DI
    00885380019794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE SUPPLIER¿S INVESTIGATION, THE DEVICE HISTORY RECORD REVIEW DID NOT INDICATE ANY EXCEPTION THAT COULD LEAD TO THE REPORTED INCIDENT. THERE WAS NO CHANGE IN THE MATERIAL COMPOSITION. ONE BOUFFANT WAS RETURNED FOR VISUAL INSPECTION, THERE WAS NO ABNORMALITY FOUND. CONSIDERING THE COMPLAINT DEFECT CATEGORY OF IRRITATION, THE SUPPLIER REVIEWED THE RAW MATERIAL AND COMPONENT INSPECTION RECORD AND THEIR EXISTING MATERIAL USED FOR THIS CODE 3274, COMPLIES TO THE SPECIFICATION AND NO EXCEPTION WAS DETECTED THAT COULD RESULT IN THIS REPORTED ISSUE. THE ELASTIC MATERIAL USED FOR THE CAP PASSED BIO-COMPATIBILITY TESTS REQUIRED BY THE REGULATORY AGENCY FOR THE INTENDED USE. BASED ON THE INVESTIGATION, THE ROOT CAUSE COULD NOT BE DETERMINED. THE COMPLAINT INFORMATION WAS PROVIDED TO THE RELEVANT SECTORS FOR THEIR AWARENESS. THERE IS NO ADDITIONAL ACTION TAKEN AT THIS TIME, BUT THE SUPPLIER WILL CONTINUE TO MONITOR THE TREND OF THIS TYPE OF INCIDENT.

    Description of Event or Problem · 1

    THE END USER-CLINICIAN EXPERIENCED RASH FROM THE ELASTIC ON BOUFFANT CAP ON FOREHEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821795 BLUE COMFORT BOUFFANT 24 IN CAP, SURGICAL FYF HUBEI SAFEWAY PROTECTIVE PRODUCTS 3274 NA 00885380019794

    Patients

    Seq Age Sex Outcome Treatment
    1 Other