BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOEY CATHETER W TEMP

    MDR report key: 6955769 · Received October 17, 2017

    Report

    Report Number
    9681860-2017-05010
    Event Type
    Injury
    Date Received
    October 17, 2017
    Date of Event
    July 13, 2017
    Report Date
    October 17, 2017
    Manufacturer
    DEGANIA SILICONE LTD
    Product Code
    DRF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT SOLD IN US AND IS 510(K) EXEMPT. THIS REPORT IS ASSOCIATED TO A SIMILAR PRODUCT SOLD IN THE US - 510(K) NUMBER K831567.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE DEVICE HAD AN UNKNOWN FAILURE. THERE WAS A PATIENT INVOLVED WITH AN UNKNOWN SERIOUS INJURY REPORTED IN THIS EVENT. MEDTRONIC IS REQUESTING ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735539 FLOEY CATHETER W TEMP CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF DEGANIA SILICONE LTD 90051T S16069490

    Patients

    Seq Age Sex Outcome Treatment
    1 Other