BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSAMPLER

    MDR report key: 33970 · Received July 8, 1996

    Report

    Report Number
    MW1009452
    Event Type
    Injury
    Date Received
    July 8, 1996
    Date of Event
    January 1, 1995
    Report Date
    July 3, 1996
    Manufacturer
    MEDICAL GYN PRODUCTS
    Product Code
    HHK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 3/28/01: MFR WOULD LIKE TO INFORM FDA THAT THE COMPLAINANT DID NOT CONTACT THEM DIRECTLY AT THE TIME OF THE COMPLAINT, AND THIS IS THE FIRST TIME MFR HAS BEEN INFORMED OF THIS INCIDENT. SINCE THE INCIDENT REPORT DOES NOT INCLUDE A LOT NUMBER, IT IS VERY DIFFICULT TO TRACE THE RECORDS TO THE SPECIFIC LOT. MFR HAS REVIEWED THE RECORDS BEFORE AND AFTER THE INCIDENT DATE AND CANNOT SEE ANYTHING UNUSUAL IN THE MFG OF THE PRODUCT. ADDITIONALLY, MFR HAS MANUFACTURED AND SOLD SEVERAL THOUSAND ENDOMETRIAL CURETTES EACH YEAR SINCE 1995 AND HAS NEVER RECEIVED COMPLAINTS OF A SIMILAR NATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSAMPLER ENDOMETRIAL CURETTE HHK MEDICAL GYN PRODUCTS

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention