BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEVICE 7040100 NETTERVILLE PHONOFORM RT

    MDR report key: 2431746 · Received January 30, 2012

    Report

    Report Number
    1045254-2012-00008
    Event Type
    Injury
    Date Received
    January 30, 2012
    Date of Event
    January 6, 2012
    Report Date
    January 6, 2012
    Manufacturer
    XOMED MFG JACKSONVILLE
    Product Code
    KHJ
    PMA / PMN Number
    K982294
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE NOT PROVIDED, NOTIFIED DATE USED. NO MEDWATCH 3500A FORM WAS RECEIVED FROM THE REPORTER. ANY MISSING OR INCOMPLETE DATA ON THIS FORM 3500A IS THE RESULT OF INFORMATION NOT BEING PROVIDED OR RELEASED BY THE REPORTER. MULTIPLE ATTEMPTS TO OBTAIN THE REQUIRED INFORMATION WERE MADE, AND THE RECORDS OF THESE ATTEMPTS ARE DOCUMENTED IN THE COMPLAINT FILE. THIS PRODUCT WAS BEING USED FOR TREATMENT, NOT DIAGNOSIS. NEITHER THE DEVICE IN QUESTION, APPLICABLE IMAGING FILMS, NOR MEDICAL RECORDS WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE REPORT IS INCONCLUSIVE AS TO THE CAUSE OF THE REPORTED PRODUCT PROBLEM. IF THE DEVICE IS RETURNED IN THE FUTURE, PRODUCT ANALYSIS MAY BE PERFORMED. THE DEVICE HAS NOT BEEN RETURNED SINCE INITIAL DISTRIBUTION. THE INFORMATION REASONABLY SUGGESTS THAT A DEVICE IN QUESTION HAS MALFUNCTIONED AS DEFINED BY THE FDA AND A REVIEW OF THE COMPLAINT HISTORY INDICATES THAT THIS PRODUCT ISSUE HAS RESULTED IN AN ADVERSE EVENT IN THE PAST AND THEREFORE IS LIKELY, AS DEFINED BY THE FDA, TO CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF THIS EVENT WERE TO RECUR. THE (B)(4) SILICONE BLOCKS ARE INTENDED FOR USE AS SPACE-OCCUPYING IMPLANTS TO AID IN SURGICAL RECONSTRUCTIONS IN LARYNGEAL SURGICAL PROCEDURES FOR VOCAL CORD MEDIALIZATION AND AUGMENTATION. (B)(4). (B)(4) SILICONE BLOCKS ARE NOT TO BE USED WHERE INSUFFICIENT TISSUE IS AVAILABLE TO COVER THE IMPLANT MATERIAL. SIZING/CUSTOMIZING RECOMMENDATIONS: THE SURGEON SHOULD BE FAMILIAR WITH OR BE TRAINED IN THE LARYNGOPLASTY AUGMENTATION TECHNIQUES, INCLUDING VOCAL CORD MEDIALIZATION WITH SILICONE ELASTOMER IMPLANT MATERIALS. PROPER SURGICAL TECHNIQUE IS THE RESPONSIBILITY OF THE SURGEON, WITH PATIENT TREATMENT BASED ON CURRENTLY ACCEPTED TECHNIQUES AND ON THE SURGEON'S TRAINING. THE FOLLOWING RECOMMENDATIONS AND WARNINGS SHOULD BE FOLLOWED TO FACILITATE CUSTOMIZATION OF THE IMPLANT MATERIAL: FOR EASE OF CUTTING WITH SHARP SCISSORS, THE BLOCK SHOULD BE MOISTENED OR DIPPED IN STERILE SALINE OR WATER PRIOR TO CUTTING. SCISSORS AND THE USER'S GLOVED HANDS MAY ALSO BE SIMILARLY MOISTENED FOR EASE OF HANDLING. USE ROUNDED OR BLUNT EDGED CUTS TO MINIMIZE BALLING OR ROLLING OF THE IMPLANT MATERIAL. BLOCKS MAY BE HELD WITH GRASPING INSTRUMENTS TO REDUCE RISK OF INJURY IN TRIMMING.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SCHEDULED PROCEDURE FOR VOCAL CORD MEDIALIZATION AND AUGMENTATION, A "TEAR IN PATIENT'S LARYNX" WAS NOTED. IT WAS NOTED THAT THE SURGEON "STUCK THE IMPLANT IN AND PULLED IT OUT SEVERAL TIMES WHILE TRYING TO ADJUST THE FIT EACH TIME." THE SURGEON "ENDED UP PUTTING A TEAR IN THE LARYNX (MAY HAVE HAPPENED WHEN THE PATIENT COUGHED) AND WAS CONCERNED ABOUT INFECTION IF THEY LEFT THE IMPLANT IN PLACE." THE SURGEON "REMOVED IT AND CLOSED WITHOUT MEDIALIZING THE CORDS." THE SURGEON "WILL HAVE TO RESCHEDULE AFTER THE PATIENT HEALS AND TRY AGAIN." ACCORDING TO THE (B)(4) COORDINATOR THE PATIENT HAS NOT RESCHEDULED AS OF YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEVICE 7040100 NETTERVILLE PHONOFORM RT POLYMER, ENT SYNTHETIC-POLYAMIDE (MESH OR FOIL MATERIAL) KHJ XOMED MFG JACKSONVILLE 7040100

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Other