BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATTERSON DENTAL

    MDR report key: 362834 · Received November 23, 2001

    Report

    Report Number
    MW1023497
    Event Type
    Injury
    Date Received
    November 23, 2001
    Date of Event
    September 1, 2001
    Report Date
    November 1, 2001
    Manufacturer
    *
    Product Code
    EMG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 2/14/02: THE PRODUCT REFERENCED IN MEDWATCH FORM, REF NUMBER 1023497 IS MFG FOR PATTERSON DENTAL CO BY DENTAFIX UK LTD, UNITS 11, 12, 13 HELIX, BUSINESS PARK WILTON RD, SURREY, ENGLAND. PATTERSON IS MERELY A DISTRIBUTOR OF THE PRODUCT, AND DOES NOT ALTER, CHANGE OR REPACKAGE THE PRODUCT. THEY BELIEVE PRIMARY RESPONSIBILITY RESTS WITH THE MFR. AS A GENERAL PROCEDURE, HOWEVER, WHENEVER THEY RECEIVE A REPORT INVOLVING PRODUCT FAILURE, THEY INVESTIGATE THE INCIDENT AND ATTEMPT TO RETRIEVE THE PRODUCT AND HAVE IT TESTED. DUE TO THE ANONYMITY OF THE RPTR, A FULL INVESTIGATION OF THIS MATTER, INCLUDING RETRIEVAL OF THE PRODUCT FOR TESTING PURPOSES HAS NOT BEEN POSSIBLE.

    Description of Event or Problem · 1

    RPTR WAS EXTRACTING TOOTH # 14 ON A SEVERELY DEVELOPMENTALLY DISABLED CHILD. RPTR WAS USING PATTERSON DENTAL BRAND OF FORCEPS #1505. AS RPTR PUT THE FORCEPS ON THE TOOTH THE BEAK OF THE FORCEPS BROKE AND FELL DOWN THE PT'S THROAT. RPTR IMMEDIATELY GRABBED THE CHILD AND HELD THEM SO THEIR HEAD WAS THE LOWEST PART OF THEIR BODY. THE BROKEN PORTION WAS COUGHED OUT. A SECOND 1505 BROKE IN THE SAME SPOT WHILE BEING CLEANED. A THIRD FORCEPS OF THE SAME SIZE AND BRAND WAS REPORTED TO HAVE BROKEN AT ONE OF RPTR'S OFFICES.

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM MFR 12-28-2001: PATTERSON DENTAL COMPANT DOES NOT MFR THIS PARTICULAR INSTRUMENT. THIS INSTRUMENT IS MANUFACTURED BY DENFIX UK LTD UNITS 11,12,13 HELIX, BUSINESS PARK WILTON ROAD, SURREY, ENGLAND. IF A SAMPLE OF THE FORCEPS WAS SUBMITTED THEY WOULD LIKE TO RETRIEVE THEM FOR THE MFR TO PERFORM TESTING.

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM MFR 4/15/02: THE PRODUCT REFERENCED IN MEDWATCH FROM IS MANUFACTURED FOR PATTERSON DENTAL COMPANY BY DENTAFIX UK LTD, UNITS 11,12,13 HELIX, BUSINESS PARK WILTON ROAD, SURREY, ENGLAND. PATTERSON IS MERELY A DISTRIBUTOR OF THE PRODUCT, AND DOES NOT ALTER, CHANGE OR REPACKAGE THE PRODUCT. THEY BELIEVE PRIMARY RESPONSIBILITY RESTS WITH THE MFR. AS A GENERAL PROCEDURE, HOWEVER, WHENEVER CO RECEIVES A REPORT INVOLVING PRODUCT FAILURE, THE CO INVESTIGATES THE INCIDENT AND ATTEMPTS TO RETRIEVE THE PRODUCT AND HAVE IT TESTED. DUE TO THE ANONYMITY OF THE REPORTER, A FULL INVESTIGATION OF THIS MATTER, INCLUDING RETRIEVAL OF THE PRODUCT FOR TESTING PURPOSES HAS NOT BEEN POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53122 PATTERSON DENTAL DENTAL FORCEPS #1505 EMG * 1505 *

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention