BEUDAMED
    FDA Adverse Event Other Summary report: N

    HENRY SCHEIN SOFT EARLOOP FACE MASK

    MDR report key: 2686979 · Received July 27, 2012

    Report

    Report Number
    9680179-2012-00001
    Event Type
    Other
    Date Received
    July 27, 2012
    Date of Event
    June 20, 2012
    Report Date
    June 20, 2012
    Manufacturer
    A.R. MEDICOM
    Product Code
    FXX
    PMA / PMN Number
    K051291
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ALL MASKS MFG BY MEDICOM UNDER THE 510K (K051291) HAVE AN OUTER LAYER, A FILTER, AND AN INNER LAYER. THE INNER LAYER OF THE MASK 103-4757 IS THE SAME MATERIAL DENSITY (B)(4) AND COMING FROM THE SAME RAW MATERIAL SUPPLIER SINCE THE 510K SUBMISSION IN 2005. CYTOTOXICITY AND SKIN IRRITATION STUDIES WERE CONDUCTED IN DECEMBER 2003, WITH THE SAME MASK CONSTRUCTION AS HS ITEM 103-4757 UNDER MEDICOM'S ITEM CODE 2115 LOT NUMBER 107558 AND THOSE STUDIES WERE INCLUDED IN THE 510K APPLICATION IN 2005. IN ADDITION, A DERMAL SENSITIZATION STUDY WAS CONDUCTED IN 2005 (MASK 2115 LOT 298809), AND WAS ALSO INCLUDED IN THE 510K SUBMISSION. THE CONCLUSION OF THOSE 3 STUDIES WERE NO ABNORMALITIES OR REACTION OBSERVED. TEN MASKS THAT CAME FROM THE SAME BOX (ITEM 103-4757 LOT 13430) AS THE HYGIENIST REACTION WERE WORN PER MEDICOM'S EMPLOYEES FOR A PERIOD BETWEEN OF 1.5 TO 2 HOURS AND NO REACTIONS WERE OBSERVED. THE MFG BATCH RECORD FOR THE ITEM 103-4747 LOT 13430 WAS REVIEWED BY THE MANUFACTURER (AR MEDICOM) AND NOTHING PARTICULAR WAS FOUND. DURING THE PERIOD BETWEEN JANUARY 2009 AND JULY 20, 2012, MEDICOM IS AWARE OF A TOTAL OF (B)(4) SKIN IRRITATION REACTION COMPLAINTS (INCLUDING THIS CASE) WITH THE SAME MASK CONSTRUCTION AND ONLY THIS REACTION REQUIRED MEDICAL ATTENTION. SINCE SEPTEMBER 2008, MORE THAN (B)(4) MASKS WITH THE SAME CONSTRUCTION WERE MFG AT AR MEDICOM (B)(4) AND WERE SOLD IN UNITED STATES AND (B)(4). IT IS KNOWN IN THE LITERATURE THAT CERTAIN PEOPLE CAN HAVE A SKIN IRRITATION REACTION WITH MASKS. THE TOTAL NUMBER OF REACTIONS WITH OUR MEDICOM CONSTRUCTION MASK IS LESS THAN 0.001% OF MASKS SOLD. MEDICOM WILL CONTINUE TO MONITOR ANY/ALL TYPES OF REACTIONS.

    Description of Event or Problem · 1

    HYGIENIST IN A DENTAL OFFICE WORE EARLOOP FACE MASK FOR SEVERAL HOURS AND EXPERIENCED A RASH/REACTION. HER LIPS SWELLED AND SHE WENT TO THE EMERGENCY ROOM AT (B)(6) HOSPITAL IN NEW YORK. AN INCISION WAS MADE TO HER LIP TO LET OUT THE INFECTION, IV ANTIBIOTIC (2 INJECTIONS) WAS PROVIDED TO HER FOLLOWED BY ORAL ANTIBIOTICS FOR A WEEK. THE HYGIENIST SAID THAT THE DOCTOR COULDN'T DRAIN ANY LIQUID FROM HER LIP INCISION. THE HYGIENIST WAS OUT OF THE DENTAL OFFICE FOR ONE WEEK AND SHE IS WELL NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HENRY SCHEIN SOFT EARLOOP FACE MASK FACE MASK FXX A.R. MEDICOM 13430

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other