BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENTAL NEEDLE

    MDR report key: 61267 · Received January 10, 1997

    Report

    Report Number
    1017768-1996-00015
    Event Type
    Injury
    Date Received
    January 10, 1997
    Date of Event
    November 15, 1994
    Report Date
    December 12, 1996
    Manufacturer
    SHERWOOD DAVIS AND GECK
    Product Code
    DZM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    SECTION H-6, CODES 86, 100, & 68 = ACTUAL SAMPLE WAS RETURNED FOR EVALUATION. METALLURGICAL ANALYSIS REVEALED THE PRODUCT WAS NOT MFR BY CO (DOMESTICALLY OR INTERNATIONALLY). ANALYSIS REVEALED THE NEEDLE IS ONE VERY SIMILAR TO THOSE PRODUCED BY SMITH AND NEPHEW MPL. CLOSING COMPLAINT-NON-CO'S PRODUCT.

    Description of Event or Problem · 1

    NEEDLE BROKE IN USE ON OR ABOUT 11/15/94. PT'S CONDITION IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DENTAL NEEDLE DENTAL NEEDLE DZM SHERWOOD DAVIS AND GECK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other