BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HENRY SCHEIN NON STERILE COTTON ROLLS #2

    MDR report key: 1659877 · Received March 5, 2010

    Report

    Report Number
    2411236-2010-00001
    Event Type
    Injury
    Date Received
    March 5, 2010
    Date of Event
    September 15, 2009
    Report Date
    February 9, 2010
    Manufacturer
    A.R MEDICOM INC.
    Product Code
    EFN
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    SINCE (B)(6) OF 2009 THE DOCTOR ALLEGES THEY HAD SIX DIFFERENT PTS EXPERIENCE VARIOUS LEVELS OF WHAT LOOKS LIKE A CHEMICAL BURN CAUSED BY THE COTTON ROLLS. SOME OF THE PTS HAD TO BE TREATED WITH ANTIBIOTICS AS A RESULT. ON (B)(6), 2009, DOCTOR PLACED COTTON ROLL IN LOWER RIGHT QUADRANT IN FRONT OF HER TEETH BEHIND LIP; PT FELT BURNING BUT DID NOT MENTION IT TO THE DOCTOR. THE PT CAME BACK TWO DAYS LATER AND EXPLAINED THERE WAS BURNING ON OTHER SIDE OF MOUTH. PT RETURNED ON (B)(6), 2010 AND WAS GIVEN A PRESCRIPTION OF ANTIBIOTICS BY THE DOCTOR. THERE WAS PEELING AND TIGHT, SCARRING TISSUE.

    Description of Event or Problem · 2

    ON (B)(6) 2010, DOCTOR WAS WORKING ON THE PT'S VERY BACK RIGHT OF MOUTH WHEN THE PT COMPLAINED OF BURNING. THE DOCTOR CLAIMS IT LOOKED LIKE A CHEMICAL BURN AND DISCOLORATION; LIP WAS BURNING. THE DOCTOR ALSO ALLEGES THE COTTON ROLLS INSTANTLY BURNED PT, NOT EVEN 30 SECONDS IN MOUTH. MOUTH WAS RINSED WITH WATER. PT WAS SEEN NEXT DAY; THE SKIN WAS COMING OFF AND PT HAD A MILD BURN.

    Description of Event or Problem · 3

    ON (B)(6) , THE PT'S MOUTH WAS NUMB WHEN THE DOCTOR WORKED ON THE LOWER RIGHT OF MOUTH. THE DOCTOR ALLEGES THE FRONT PART OF MOUTH WAS FROZEN, THEREFORE, PT DID NOT FEEL THE BURNING. ONE MONTH LATER THE PT CAME BACK TO THE OFFICE AND COMPLAINED OF A BURN AND SCAR. PT WENT TO PHYSICIAN FOR ANTIBIOTICS AS THE INFECTION HAD SET IN. DOCTOR CLAIMS THE BURN TOOK ONE MONTH TO HEAL AND PT HAD SCARRING.

    Description of Event or Problem · 4

    ON (B)(6) 2010, THE DOCTOR CLAIMS THE PT HAS A BURN ON THE INSIDE OF LIP EXACTLY THE SAME SHAPE OF THE COTTON ROLL. THE PT INSTANTLY COMPLAINED WHEN PLACED IN THE MOUTH THAT THE COTTON ROLL BURNED. PT CALLED THE DOCTOR BACK A FEW TIMES ALLEGING THAT IT FEELS LIKE HE HAS A PAPER STUCK TO HIS LIP AND IT FEELS LIKE A CHEMICAL BURN WITHOUT THE PAIN.

    Description of Event or Problem · 5

    ON (B)(6) 2010, THE DOCTOR PERFORMED SOME FILLINGS IN THE FRONT OF MOUTH. DURING A FOLLOW UP VISIT, EIGHT DAYS LATER, THE PT TOLD THE DOCTOR OF A BURN IN THE FRONT OF MOUTH LIKE A LARGE CANKER SORE.

    Description of Event or Problem · 6

    ON (B)(6) 2009, THE PT WAS HAVING A BRIDGE PREP ON 3-6 AREA; A COTTON ROLL WAS PLACED IN THE UPPER AREA OF MOUTH. THE NEXT DAY THE PT ENDED UP WITH A HUGE CANKER SORE WHICH TOOK TEN DAYS TO HEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HENRY SCHEIN NON STERILE COTTON ROLLS #2 NON STERILE COTTON ROLLS #2 EFN A.R MEDICOM INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other
    2 43 YR Other
    3 15 YR Other
    4 47 YR Other
    5 43 DA Other
    6 35 YR Other