BEUDAMED
    FDA Adverse Event Other Summary report: N

    STAN S31 FETAL HEART MONITOR

    MDR report key: 2281239 · Received September 23, 2011

    Report

    Report Number
    3004729605-2011-00002
    Event Type
    Other
    Date Received
    September 23, 2011
    Date of Event
    September 8, 2011
    Report Date
    September 21, 2011
    Manufacturer
    NEOVENTA MEDICAL AB
    Product Code
    HEO
    PMA / PMN Number
    P020001
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT TOOK PLACE AT (B)(6), WHO ARE PARTICIPATING IN A (B)(4) TRIAL. THE EVENT WAS REPORTED TO NEOVENTA AS A STUDY ADVERSE EVENT (NOT SERIOUS). THE LEGPLATE CABLE HAS BEEN EXCHANGED. NEOVENTA CONCLUDES THAT THE EVENT IS RELATED TO THE CONCOMITANT PRODUCT: (B)(4) LEG PLATE ((B)(4)). THE EVENT WILL THEREFORE BE REPORTED TO THE PRODUCER OF THIS PRODUCT: (B)(4).

    Description of Event or Problem · 1

    AFTER DELIVERY, THE LEG PLATE WAS DISCONNECTED BY THE RESEARCH RN WHO DID NOT NOTE ANY LESION AT THE TIME. AFTER THE PT WAS TRANSFERRED TO THE POSTPARTUM ROOM HER MOTHER NOTICED A BLISTER ON THE RIGHT THIGH AND INFORMED CLINICAL NURSE. THE BLISTER WAS ABOUT 1CM IN DIAMETER WITH SURROUNDING ERYTHEMA AT THE LOCATION OF THE LEG PLATE PLACEMENT. THE REGULAR STAN STRAP HAD BEEN USED AND THE PT WAS ON STAN FROM (B)(6) 2011 AT 20:30 TO (B)(6) 2011 AT 09:10. THE PT DID REPORT A TENDENCY FOR EASY BRUISING. THE LESION WAS BEGINNING TO HEAL BY THE TIME SHE LEFT THE HOSP. THE BLISTER WAS TREATED WITH ANTIBIOTIC OINTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAN S31 FETAL HEART MONITOR HEO: OBSTETRIC DATA ANALYZER HEO NEOVENTA MEDICAL AB SYS 101003

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4) LEG PLATE ((B)(4))