BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROTARGETING MICROTABLE - SINGLE

    MDR report key: 8939253 · Received August 28, 2019

    Report

    Report Number
    3002250546-2019-00005
    Event Type
    Injury
    Date Received
    August 28, 2019
    Date of Event
    June 10, 2019
    Report Date
    August 28, 2019
    Manufacturer
    FHC, INC,
    Product Code
    HAW
    UDI-DI
    00873263006436
    PMA / PMN Number
    K132611
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS ORIGINALLY SUBMITTED ON 06/24/2019 BUT DUE TO A TECHNICAL ERROR, IT DID NOT UPLOAD.

    Description of Event or Problem · 1

    FHC RECEIVED INFORMATION REGARDING AN EVENT RELATING TO THE FHC MICROTABLE, MODEL # 66-MT-D1, SN# (B)(4). THE PATIENT SUFFERED A HEMORRHAGE AND STROKE. PHYSICIAN NOTED THAT THIS WAS NOT THE RESULT OF AN ISSUE WITH THE MICROTABLE. THE MICROTABLE WAS CREATED AND STERILIZED ACCORDING TO THE PLAN FROM THE CT SCANS. THE CASE WENT WELL AND UNEVENTFUL WITH NO INJURY OR CONCERN OF INJURY TO THE PATIENT. THERE WERE 4 BIOPSIES PREPARED AS SPECIMEN FOR PATHOLOGY. THERE WERE AT LEAST 6 PASSES WITH THE BRAIN LAB BIOPSY NEEDLE PERFORMED. THERE WAS NO SIGNIFICANT BLOOD LOSS DURING THE PROCEDURE. THE PATIENT WAS AWAKENED FROM ANESTHESIA AND EXTUBATED. THE PATIENT WAS THEN MOVED TO RECOVERY. RECOVERY ROOM NURSE LATER CALLED THE PHYSICIAN INDICATING THAT THE PATIENT WAS NOT WAKING UP. THE PATIENT WAS EXTUBATED, BREATHING ON HER OWN AND STABLE. AS OF THE DATE OF THIS REPORT, THE PATIENT WAS IN STABLE CONDITION THE MORNING OF (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734495 MICROTARGETING MICROTABLE - SINGLE STEREOTAXIC INSTRUMENT HAW FHC, INC, 66-MT-D1 00873263006436

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization