BEUDAMED
    FDA Adverse Event Other Summary report: N

    HENRY SCHEIN NON STERILE COTTON ROLLS #2

    MDR report key: 1632532 · Received March 15, 2010

    Report

    Report Number
    9680179-2010-00001
    Event Type
    Other
    Date Received
    March 15, 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
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD EVAL: BIOCOMPATIBILITY TESTS (RETESTING). RESULTS NOT YET AVAILABLE. (INITIAL TESTING RESULTS ARE AVAILABLE BUT THE TESTING RESULTS CONDUCTED ON COMPLAINT SAMPLES ARE STILL TO COME). CONCLUSION: THIS TYPE OF INCIDENT WAS REPORTED EXCLUSIVELY BY ONE COMPLAINANT, DR (B)(6). BASED ON THE VOLUME OF THESE PRODUCTS THAT HAVE BEEN IN USE ON THE MARKET SINCE NOV 2008, THE ACCEPTABLE BIOCOMPATIBILITY TESTS RESULTS OBTAINED ON ONE OF THE FIRST BATCHES OF PRODUCTS MFG AS DESCRIBED, AND THE FACT THAT NO OTHER INCIDENT OF THIS NATURE WAS EVER BROUGHT TO OUR ATTENTION, WE HAVE NO CLEAR EVIDENCE THAT THE INJURIES REPORTED BY DR (B)(6) ARE DIRECTLY RELATED TO THE COTTON ROLLS. WE MANUFACTURE AND DISTRIBUTE THIS PRODUCT ON OTHER MARKETS (B)(4), AND NO OTHER SIMILAR COMPLAINT WAS FILED FOR THIS PRODUCT OR FOR ANY OTHER BRANDS OF THE SIMILAR COTTON ROLLS THAT WE MANUFACTURE.

    Description of Event or Problem · 1

    SINCE (B)(6) 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. THE PT WAS TREATED 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 GIVEN A PRESCRIPTION OF ANTIBIOTICS BY THE DOCTOR. THERE WAS PEELING AND TIGHT, SCARRING TISSUE.

    Additional Manufacturer Narrative · 2

    METHOD EVAL: BIOCOMPATIBILITY TESTS (RETESTING). RESULTS NOT YET AVAILABLE. (INITIAL TESTING RESULTS CONDUCTED ON COMPLAINT SAMPLES ARE STILL TO COME). CONCLUSION: THIS TYPE OF INCIDENT WAS REPORTED EXCLUSIVELY BY ONE COMPLAINANT, DR (B)(6). BASED ON THE VOLUME OF THESE PRODUCTS THAT HAVE BEEN IN USE ON THE MARKET SINCE NOV 2008, THE ACCEPTABLE BIOCOMPATIBILITY TESTS RESULTS OBTAINED ON ONE OF THE FIRST BATCHES OF PRODUCTS MFG AS DESCRIBED, THE FACT THAT NO OTHER INCIDENT OF THIS NATURE WAS EVER BROUGHT TO OUR ATTENTION, WE HAVE NO CLEAR EVIDENCE THAT THE INJURIES REPORTED BY DR (B)(6) ARE DIRECTLY RELATED TO THE COTTON ROLLS. WE MFR AND DISTRIBUTE THIS PRODUCT ON OTHER MARKETS (B)(4) AND NO OTHER SIMILAR COMPLAINT WAS FILED FOR THIS PRODUCT OR FOR ANY OTHER BRANDS OF THE SIMILAR COTTON ROLLS THAT WE MANUFACTURE.

    Description of Event or Problem · 2

    SINCE (B)(6) 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. THE PT A (B)(6) FEMALE WAS SEEN 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.

    Additional Manufacturer Narrative · 3

    METHOD EVAL: BIOCOMPATIBILITY TESTS (RETESTING). RESULTS NOT YET AVAILABLE. (INITIAL TESTING RESULTS CONDUCTED ON COMPLAINT SAMPLES ARE STILL TO COME). CONCLUSION: THIS TYPE OF INCIDENT WAS REPORTED EXCLUSIVELY BY ONE COMPLAINANT, DR (B)(6). BASED ON THE VOLUME OF THESE PRODUCTS THAT HAVE BEEN IN USE ON THE MARKET SINCE NOV 2008, THE ACCEPTABLE BIOCOMPATIBILITY TESTS RESULTS OBTAINED ON ONE OF THE FIRST BATCHES OF PRODUCTS MFG AS DESCRIBED, THE FACT THAT NO OTHER INCIDENT OF THIS NATURE WAS EVER BROUGHT TO OUR ATTENTION, WE HAVE NO CLEAR EVIDENCE THAT THE INJURIES REPORTED BY DR (B)(6) ARE DIRECTLY RELATED TO THE COTTON ROLLS. WE MFR AND DISTRIBUTE THIS PRODUCT ON OTHER MARKETS (B)(4) AND NO OTHER SIMILAR COMPLAINT WAS FILED FOR THIS PRODUCT OR FOR ANY OTHER BRANDS OF THE SIMILAR COTTON ROLLS THAT WE MANUFACTURE.

    Description of Event or Problem · 3

    SINCE (B)(6) 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. THE PATIENT A (B)(6) FEMALE WAS SEEN ON (B)(6) 2009. 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, THE 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.

    Additional Manufacturer Narrative · 4

    METHOD EVAL: BIOCOMPATIBILITY TESTS (RETESTING). RESULTS NOT YET AVAILABLE. (INITIAL TESTING RESULTS CONDUCTED ON COMPLAINT SAMPLES ARE STILL TO COME). CONCLUSION: THIS TYPE OF INCIDENT WAS REPORTED EXCLUSIVELY BY ONE COMPLAINANT, DR (B)(6). BASED ON THE VOLUME OF THESE PRODUCTS THAT HAVE BEEN IN USE ON THE MARKET SINCE NOV 2008, THE ACCEPTABLE BIOCOMPATIBILITY TESTS RESULTS OBTAINED ON ONE OF THE FIRST BATCHES OF PRODUCTS MFG AS DESCRIBED, THE FACT THAT NO OTHER INCIDENT OF THIS NATURE WAS EVER BROUGHT TO OUR ATTENTION, WE HAVE NO CLEAR EVIDENCE THAT THE INJURIES REPORTED BY DR (B)(6) ARE DIRECTLY RELATED TO THE COTTON ROLLS. WE MFR AND DISTRIBUTE THIS PRODUCT ON OTHER MARKETS (B)(4) AND NO OTHER SIMILAR COMPLAINT WAS FILED FOR THIS PRODUCT OR FOR ANY OTHER BRANDS OF THE SIMILAR COTTON ROLLS THAT WE MANUFACTURE.

    Description of Event or Problem · 4

    SINCE (B)(6) 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. THE PT A (B)(6) MALE SEEN 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.

    Additional Manufacturer Narrative · 5

    METHOD EVAL: BIOCOMPATIBILITY TESTS (RETESTING). RESULTS NOT YET AVAILABLE. (INITIAL TESTING RESULTS CONDUCTED ON COMPLAINT SAMPLES ARE STILL TO COME). CONCLUSION: THIS TYPE OF INCIDENT WAS REPORTED EXCLUSIVELY BY ONE COMPLAINANT, DR (B)(6). BASED ON THE VOLUME OF THESE PRODUCTS THAT HAVE BEEN IN USE ON THE MARKET SINCE NOV 2008, THE ACCEPTABLE BIOCOMPATIBILITY TESTS RESULTS OBTAINED ON ONE OF THE FIRST BATCHES OF PRODUCTS MFG AS DESCRIBED, THE FACT THAT NO OTHER INCIDENT OF THIS NATURE WAS EVER BROUGHT TO OUR ATTENTION, WE HAVE NO CLEAR EVIDENCE THAT THE INJURIES REPORTED BY DR (B)(6) ARE DIRECTLY RELATED TO THE COTTON ROLLS. WE MFR AND DISTRIBUTE THIS PRODUCT ON OTHER MARKETS (B)(4) AND NO OTHER SIMILAR COMPLAINT WAS FILED FOR THIS PRODUCT OR FOR ANY OTHER BRANDS OF THE SIMILAR COTTON ROLLS THAT WE MANUFACTURE.

    Description of Event or Problem · 5

    SINCE (B)(6) 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. THE PT A (B)(6) FEMALE WAS SEEN ON (B)(6) 2010. THE DOCTOR HAD PERFORMED SOME FILLINGS IN THE FRONT OF THE MOUTH. DURING A F/U VISIT, EIGHT DAYS LATER, THE PT TOLD THE DOCTOR OF A BURN IN THE FRONT OF MOUTH LIKE A LARGE CANKER SORE.

    Additional Manufacturer Narrative · 6

    METHOD EVAL: BIOCOMPATIBILITY TESTS (RETESTING). RESULTS NOT YET AVAILABLE. (INITIAL TESTING RESULTS CONDUCTED ON COMPLAINT SAMPLES ARE STILL TO COME). CONCLUSION: THIS TYPE OF INCIDENT WAS REPORTED EXCLUSIVELY BY ONE COMPLAINANT, DR (B)(6). BASED ON THE VOLUME OF THESE PRODUCTS THAT HAVE BEEN IN USE ON THE MARKET SINCE NOV 2008, THE ACCEPTABLE BIOCOMPATIBILITY TESTS RESULTS OBTAINED ON ONE OF THE FIRST BATCHES OF PRODUCTS MFG AS DESCRIBED, THE FACT THAT NO OTHER INCIDENT OF THIS NATURE WAS EVER BROUGHT TO OUR ATTENTION, WE HAVE NO CLEAR EVIDENCE THAT THE INJURIES REPORTED BY DR (B)(6) ARE DIRECTLY RELATED TO THE COTTON ROLLS. WE MFR AND DISTRIBUTE THIS PRODUCT ON OTHER MARKETS (B)(4) AND NO OTHER SIMILAR COMPLAINT WAS FILED FOR THIS PRODUCT OR FOR ANY OTHER BRANDS OF THE SIMILAR COTTON ROLLS THAT WE MANUFACTURE.

    Description of Event or Problem · 6

    SINCE (B)(6) 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. THE PT A (B)(6) FEMALE SEEN ON (B)(6) 2009. THE PT WAS HAVING A BRIDGE PRE 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
    5 43 YR Other
    6 35 YR Other