BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETER W TEMP

    MDR report key: 6785232 · Received August 10, 2017

    Report

    Report Number
    1219161-2017-05001
    Event Type
    Malfunction
    Date Received
    August 10, 2017
    Date of Event
    July 13, 2017
    Report Date
    August 8, 2017
    Manufacturer
    DEGANIA SILICONE LTD.
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED A NOTIFICATION THAT AN ALLEGED CUFF BURST WHILE IT WAS IN THE BLADDER OF THE PATIENT BUT IT DID NOT SEPARATE FROM THE CATHETER. MEDTRONIC IS REQUESTING ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566846 FOLEY CATHETER W TEMP CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF DEGANIA SILICONE LTD. 90056T S16039128

    Patients

    Seq Age Sex Outcome Treatment
    1