BEUDAMED
    FDA Adverse Event Death Summary report: N

    N/A

    MDR report key: 4963 · Received May 17, 1993

    Report

    Report Number
    4963
    Event Type
    Death
    Date Received
    May 17, 1993
    Date of Event
    April 23, 1993
    Report Date
    April 30, 1993
    Manufacturer
    CARELINK
    Product Code
    MHX
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PATIENT MONITORED USING DEVICE IN A.M. OF 4/22/93. DEVICE RECORDED THREE UTERINE CONTRACTIONS DURING THAT SESSION. PATIENT DENIED SIGNS AND SYMPTOMS ASSOCIATED WITH LABOR. SHE PROCEEDED TO SCHEDULED PHYSICIAN APPOINTMENT. HER PHYSICIAN DID A CERVICAL EXAM AND DETERMINED CERVIX HAD DILATED TO 4 CMS. PATIENT WAS SENT TO HOSPITAL AND DELIVERED A LIVE BORN INFANT SON AFTER ADMISSION. INFANT EXPIRED ON 4/23/93 DUE TO COMPLICATIOLNS RELATED TO PREMATURITY. DEVICE WAS SENT TO MANUFACTURER FOR EVALUATION ON 4/29/93DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-FEB-93. SERVICE PROVIDED BY: MANUFACTURER. SERVICE RECORDS AVAILABLE.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: INVALID DATA. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR, DEVICE TEMPORARILY REMOVED FROM SERVICE. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A TERM GUARD I MHX CARELINK N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Death