BEUDAMED
    FDA Adverse Event Summary report: N

    DISPOSO SPEC

    MDR report key: 144622 · Received January 6, 1998

    Report

    Report Number
    1925197-1998-00001
    Date Received
    January 6, 1998
    Report Date
    January 8, 1998
    Manufacturer
    MONARCH MOLDING, INC.
    Product Code
    HIB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    MEDWATCH REPORT SENT ON 12/12/97 REC'D ON 12/16/1997. MEDWATCH REPORT SENT ON 12/17/97. REC'D ON 1/5/98, WITH FORM 3500A (A-E PART) CO WILL FILL OUT REPORT AND ADD SECTION H WHICH WAS NOT SENT TO CO JUST THE INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSO SPEC PLASTIC DISPOSABLE SPECULUM HIB MONARCH MOLDING, INC. SMALL VAGINAL SPECULUM DE0000977/DE00001328

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other SAME CASE OF 100 EACH.| DEVICE NOT RETURNED FOR EVALUATION NOR A PART FROM