BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNOSAMPLER

    MDR report key: 17238 · Received January 10, 1994

    Report

    Report Number
    2246681-1993-00001
    Event Type
    Injury
    Date Received
    January 10, 1994
    Date of Event
    November 17, 1993
    Report Date
    December 3, 1993
    Manufacturer
    HOMESTEEL - ACHEL N.V.
    Product Code
    HFF
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN PERFORMED ENDOMETRIAL BIOPSY ON 11/16/93. RESULTS NEGATIVE. PT CALLED PHYSICIAN ON 11/17/93 STATING SHE HAD ABDOMINAL PAIN AND FEVER. SHE WAS ADMITTED TOHOSPITAL. CERVICAL CULTURE, URINE CULTURE, AND BLOOD CULTURE WERE PERFORMED. PT WAS DIAGNOSED WITH BETA-STREP INFECTION OF CERVIX. SHE WAS TREATED WITH ROCEPHIN, FLAGYL, AND ERTHROMYCIN. SHE WAS ALSO GIVEN TYLENOL WITH CODEINE FOR PAIN. PT WAS DISCHARGED FROMHOSPITAL 11/22/93. SHE IS DOING MUCH BETTER. SHE DID DEVELOP AN ALLERGY TO ONE OF THE ANTIBIOTICS. PHYSICIAN IS NOT SURE WHICH ONE. SHE IS SCHEDULED FOR FOLLOW-UP EXAM IN ONE WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNOSAMPLER ENDOMETRICAL ASPIRATOR HFF HOMESTEEL - ACHEL N.V. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention