BEUDAMED
    FDA Adverse Event Summary report: N

    PROVOX XTRAFLANGE

    MDR report key: 6019828 · Received October 12, 2016

    Report

    Report Number
    8032044-2016-00010
    Date Received
    October 12, 2016
    Date of Event
    September 16, 2016
    Report Date
    October 6, 2016
    Manufacturer
    ATOS MEDICAL AB
    Product Code
    EWL
    PMA / PMN Number
    K092593
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS RELATED TO REPORT (B)(4) PROVOX XTRAFLANGE US (MFR # 8032044-2016-00009) BUT AS THE EVENT IS DIFFERENT IT IS REPORTED SEPARATELY. REPORTABLE BECAUSE IF THE EVENT WOULD REOCCUR THE DEVICE COULD FALL INTO THE TRACHEA WITH RISK FOR CLINICAL COMPLICATIONS. INVESTIGATION: NEITHER THE VOICE PROSTHESIS NOR XTRAFLANGE HAS BEEN RETURNED; INVESTIGATION OF PRODUCTS IS THEREFORE NOT POSSIBLE. ALTHOUGH WE HAVE NOT BEEN ABLE TO EXAMINE IF THE DETAILS HAD ANY DAMAGES, THERE IS NO REASON TO BELIEVE THAT THE VOICEPROSTHESIS AND XTRAFLANGE DISLODGED DUE TO PRODUCT MALFUNCTION. DISCUSSION: A LEAKAGE AROUND THE PUNCTURE IS MOST OFTEN RELATED TO THE QUALITY OF THE PUNCTURE. E.G. A PUNCTURE THAT IS CREATED WITH A SCALPEL CAN BECOME KEYHOLE SHAPED. (THIS IS AVOIDED IF A VEGA PUNCTURE SET IS USED.) A WEAK OR MISS-SHAPED PUNCTURE GIVES LESS RETENTION FORCE TOWARDS THE VOICE PROSTHESIS T-FLANGE AND E-FLANGE. THIS MEANS THAT THE VOICE PROSTHESIS WILL BE MORE PRONE TO DISLODGE. CONCLUSION/ACTION: BASED ON THE FACT THAT AN XTRAFLANGE IS USED, WE ASSUME THAT THIS PATIENT HAS HAD SOME KIND OF ISSUE WITH THE PUNCTURE AND PROBLEM WITH LEAKAGE AROUND THE PROSTHESIS. IT IS POSSIBLE TO USE A VEGA XTRASEAL TOGETHER WITH AN XTRAFLANGE, WHICH MIGHT GIVE A BETTER FIXATION OF THE DEVICE.

    Description of Event or Problem · 1

    PATIENT USES THE PROVOX VEGA VOICE PROSTHESIS WITH AN XTRAFLANGE ACCESSORY, IN ADDITION TO A PROVOX LARYTUBE. COMPLAINT DESCRIPTION: LOCAL REPRESENTATIVE WAS CALLING TO FOLLOW UP WITH THE PATIENT REGARDING A PREVIOUS COMPLAINT (# (B)(4)). THE PATIENTS WIFE RITA STATED THAT THE PATIENT IS FINE AND AFTER THE INCIDENT THEY WENT HOME AND COULD NOT FIND THE XTRAFLANGE AFTER LOOKING EVERYWHERE FOR IT. WITHIN A DAY OR SO PER THE WIFE, THE ADDITIONAL XTRAFLANGE AND VOICE PROSTHESES THAT WAS BEING USED WAS THEN DISLODGED AND COUGHED OUT BY THE PATIENT INTO HIS HAND. THE PATIENT CALLED AND WENT BACK INTO THE FACILITY AND WAS SEEN BY THE SLP AGAIN. HE STATED TO THE SLP THAT IT WAS HIS FAULT AND HE MAY HAVE MADE IT COME LOOSE AND WHEN COUGHING IT BECAME DISLODGED. THE SLP RESIZED THE PATIENT AND PT. NOW HAS A NEW SMALLER SIZE VP THAT IS IN PLACE CURRENTLY. NOTE: THERE IS NO PRODUCT TO RETURN FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673715 PROVOX XTRAFLANGE VOICE PROSTHESIS (ACCESSORY) EWL ATOS MEDICAL AB 1603093

    Patients

    Seq Age Sex Outcome Treatment
    1