BEUDAMED
    FDA Adverse Event Summary report: N

    MANOSHIELD BY SIERRA

    MDR report key: 1337201 · Received March 4, 2009

    Report

    Report Number
    1337201
    Date Received
    March 4, 2009
    Date of Event
    February 26, 2009
    Report Date
    March 4, 2009
    Manufacturer
    SIERRA SCIENTIFIC INSTRUMENTS, INC.
    Product Code
    FFX
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ESOPHAGEAL MOTILITY TUBE COVERED BY MANOSHIELD SHEATH WAS INSERTED INTO PATIENT VIA LEFT NOSTRIL. THE TUBE WAS PULLED BACK ON TO GET IT IN THE CORRECT POSITION. IT WAS NOTICED THAT THE SHEATH WAS TORN CIRCUMVENTALLY. THE STUDY WAS CONTINUED DUE TO PATIENT'S NEED. UPON COMPLETION, THE TUBE WAS REMOVED AND THE OTHER HALF OF SHEATH WAS INTACT ON THE MOTILITY TUBE. THE MFR REP WAS CALLED. HE SAID TO KEEP USING SHEATH IT WAS PROBABLY AN ISOLATED INCIDENT. HE WILL MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANOSHIELD BY SIERRA CATHETER SHEATH, MANOMETRY CATHETER FFX SIERRA SCIENTIFIC INSTRUMENTS, INC. * 4808 PART #2155

    Patients

    Seq Age Sex Outcome Treatment
    1 *