BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUE BOUFFANT, 24"

    MDR report key: 3799720 · Received May 8, 2014

    Report

    Report Number
    1423537-2014-00015
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 14, 2014
    Report Date
    May 8, 2014
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FYF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION WAS DETECTED THAT COULD HAVE RESULTED IN THE REPORTED DEFECT. HISTORICAL TRENDING WAS DONE, AND THIS IS THE FIRST REPORTED INCIDENT IN THE PAST 12 MONTHS. THE ACTUAL BOUFFANT WORN WAS NOT AVAILABLE. HOWEVER, SAMPLES FROM THE SAME BOX WERE EVALUATED AGAINST RAW MATERIAL AND PRODUCT SPECIFICATION. THE BOUFFANTS MET BOTH RAW MATERIAL AND PRODUCT SPECIFICATION REQUIREMENTS. A REVIEW OF THE SAMPLES DID NOT SHOW ANY ABNORMALITY. THE MATERIAL USED FOR THE BOUFFANT IS POLYPROPYLENE WITH CALCIUM CARBONATE WHICH PASSED BIOCOMPATIBILITY TESTS PRESCRIBED BY THE REGULATORY AGENCY FOR THE INTENDED USE, AND THERE WAS NO CHANGE IN THE MATERIAL COMPOSITION, INCLUDING ELASTIC AND THREAD. THE ROOT CAUSE COULD NOT BE DETERMINED. THE COMPLAINT INFORMATION WAS FEDBACK TO THE RELATED PERSONNEL FOR AWARENESS. THERE IS NO CORRECTIVE ACTION AT THIS TIME, BUT WE WILL CONTINUE TO MONITOR COMPLAINTS FOR ANY TRENDS OF THIS NATURE.

    Description of Event or Problem · 1

    THE PATIENT WAS HAVING A PERMANENT PACEMAKER IMPLANTED. ALL PATIENTS MUST WEAR A HEAD COVERING. AT THE CONCLUSION OF THE IMPLANT, THE PATIENT HAD REDNESS AND ITCHING ON HER HEAD. SHE WAS GIVEN IV BENADRYL, NO OTHER TREATMENT WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277363 BLUE BOUFFANT, 24" CAP, SURGICAL FYF CARDINAL HEALTH 13LCB311

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Other