BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SL FOLEY SWIVEL SILICONE TRICOT

    MDR report key: 3881648 · Received April 8, 2014

    Report

    Report Number
    1018233-2014-00074
    Event Type
    Malfunction
    Date Received
    April 8, 2014
    Date of Event
    February 21, 2014
    Report Date
    March 13, 2014
    Manufacturer
    DAVOL SURGICAL INNOVATIONS
    Product Code
    EYJ
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STATLOCK SPUN AND KINKED OFF THE CATHETER, CAUSING URINE RETENTION IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212047 SL FOLEY SWIVEL SILICONE TRICOT EYJ DAVOL SURGICAL INNOVATIONS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1