BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    (2BO)ACCESS SHEATH CH12-14

    MDR report key: 5057070 · Received September 4, 2015

    Report

    Report Number
    9610711-2015-00030
    Event Type
    Malfunction
    Date Received
    September 4, 2015
    Date of Event
    July 30, 2015
    Report Date
    September 3, 2015
    Manufacturer
    COLOPLAST A/S
    Product Code
    FED
    PMA / PMN Number
    K140523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ACCORDING TO THE INFORMATION RECEIVED, AT THE INTRODUCTION OF THE SHEATH ON THE GUIDE, THE DISTAL END OF THE GUIDE DISSOCIATED; PREVENTING ITS PROGRESSION. A URETERAL FALSE ROAD LEAD TO SURGEON REDOING THE ROAD. NO CLINICAL CONSEQUENCES FOR THE PATIENT. CHANGE OF DEVICE. COMPLAINT WAS RECEIVED, NO FURTHER INVESTIGATION REQUESTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590019 (2BO)ACCESS SHEATH CH12-14 URETERAL ACCESS SHEATH FED COLOPLAST A/S ACXL121002 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R