BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLUE COMFORT BOUFFANT 24 IN

    MDR report key: 4950675 · Received July 29, 2015

    Report

    Report Number
    1423537-2015-00055
    Event Type
    Malfunction
    Date Received
    July 29, 2015
    Date of Event
    June 29, 2015
    Report Date
    July 29, 2015
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FYF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS TO OBTAIN SAMPLES FROM THE CUSTOMER WERE MADE AND THE SAMPLES HAVE JUST BEEN RECEIVED. THEREFORE; A FOLLOW UP REPORT WILL BE FILED ONCE THE SAMPLE EVALUATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S SAMPLE WAS RECEIVED FOR EVALUATION. A REVIEW OF THE RETURNED SAMPLE DID NOT INDICATE ANY ABNORMAL FINDINGS THAT WOULD RESULT IN THE ALLERGIC REACTION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED AS NO LOT NUMBER WAS PROVIDED. A REVIEW OF RAW MATERIAL RECORDS FOR THE CURRENT PRODUCTION INDICATED THAT THE MATERIAL USED WAS APPROVED AND IN COMPLIANCE WITH THE REQUIRED SPECIFICATIONS. THE MATERIAL USED FOR THE BOUFFANT IS POLYPROPYLENE WITH CALCIUM CARBONATE FILLERS, WHICH PASSED THE BIOCOMPATIBILITY TESTS PRESCRIBED BY THE REGULATORY AGENCY FOR THE INTENDED USE. THERE WERE NO CHANGES TO THE MATERIAL COMPOSITION INCLUDING ELASTIC AND THREAD. THEREFORE, BASED ON THESE FINDINGS WE ARE UNABLE TO DETERMINE THE ROOT CAUSE FOR THE ISSUE REPORTED. NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. WE WILL CONTINUE TO MONITOR FOR ANY SIMILAR REPORTS.

    Description of Event or Problem · 1

    THE PATIENT HAS ALLERGY CONDITIONS AND DEVELOPED A RASH AROUND HER HAIRLINE WHERE THE CAP FIT. CAPS ARE LATEX FREE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495102 BLUE COMFORT BOUFFANT 24 IN BLUE COMFORT BOUFFANT FYF CARDINAL HEALTH 3274 NO LOT GIVEN

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other