BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R-PEAN FCPS 6-1/4 CVD MIRROR

    MDR report key: 3381897 · Received September 3, 2013

    Report

    Report Number
    2523190-2013-00056
    Event Type
    Malfunction
    Date Received
    September 3, 2013
    Date of Event
    June 30, 2013
    Report Date
    September 3, 2013
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    NMF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    (B)(4). KELLY CLAMP WAS HANDED TO DOCTOR BY CERTIFIED SURGICAL TECHNOLOGIST (CST) AT DELIVERY TO CLAMP THE UMBILICAL CORD TO OBTAIN A SEGMENT OF CORD BLOOD. THE HEAD OF THE CLAMP BROKE AWAY FROM THE BODY OF THE CLAMP WHEN SHE ATTEMPTED TO LOCK THE HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436504 R-PEAN FCPS 6-1/4 CVD MIRROR NA NMF INTEGRA YORK, PA INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR