BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOUNDARY BOUFFANT CAPS

    MDR report key: 1908870 · Received November 19, 2010

    Report

    Report Number
    MW5018282
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 19, 2010
    Manufacturer
    BOUNDARY MEDICAL
    Product Code
    FYF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT BEING PREPPED FOR ROUTINE DENTAL PROCEDURE, AFTER A BLUE BOUFFANT SURGICAL CAP WAS PLACED OVER PT'S HAIR, A RED SPLOTCHY, SMALL BUMPS RASH WAS NOTICED APPROX TEN MINUTES AFTER PLACEMENT ON PT'S HEAD; THE RASH FOLLOWED THE LINES OF THE ELASTIC BAND OF THE CAP ACROSS THE PT'S FOREHEAD AND TEMPLE AREAS OF EACH SIDE OF THE HEAD; CHEEKS BECAME PINKISH RED AND PT DEVELOPED SAME BUMPY RASH ON THE LEFT SIDE OF NECK AND UPPER MID-CHEST AREA; RASH WAS NON-ITCHY AND PT DID NOT EXPERIENCE ANY TONGUE SWELLING OR DIFFICULTY BREATHING; BOUFFANT CAP WAS REMOVED IMMEDIATELY; AND RASH BEGAN TO DISAPPEAR IMMEDIATELY AFTER REMOVAL OF THE CAP. DATES OF USE: (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: SURGICAL ATTIRE DURING SURGICAL PROCEDURE. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOUNDARY BOUFFANT CAPS SPUNBOND POLYPROPYLENE FYF BOUNDARY MEDICAL NA 1004845919

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other