BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFE TRACE

    MDR report key: 8592 · Received May 25, 1994

    Report

    Report Number
    8592
    Event Type
    Injury
    Date Received
    May 25, 1994
    Date of Event
    May 11, 1994
    Report Date
    May 24, 1994
    Manufacturer
    GRAPHIC CONTROLS, INC.
    Product Code
    HGP
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    NEONATE BORN 5/11/90. READMITTED WITH INFLAMMED INDURATED AREA SURROUNDING SCALP SKIN ELECTRODE SITE. CELLULITIS OF SCALP RULEOUT SEPSIS.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: NONE OR UNKNOWN. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFE TRACE FETAL SCALP ELECTRODE HGP GRAPHIC CONTROLS, INC. FSE1000

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention