BEUDAMED
    FDA Adverse Event Other Summary report: N

    BLOM-SINGER

    MDR report key: 966282 · Received December 14, 2007

    Report

    Report Number
    2025182-2007-00004
    Event Type
    Other
    Date Received
    December 14, 2007
    Date of Event
    November 18, 2007
    Report Date
    December 12, 2007
    Manufacturer
    HELIX MEDICAL, LLC
    Product Code
    EWL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER REPORTING HEALTH PROFESSIONAL: TISSUE INTEGRITY AROUND PUNCTURE SITE IS 'NOT GOOD'. SIZING PRIOR TO INSERTION OF DEVICE IS NOT TYPICALLY DONE DUE TO TISSUE BLEEDING AND SPASMING ISSUES. RESULTS OF ANALYSIS: EXAMINATION OF THE RETURNED DEVICE REVEALED THE DISTAL FLANGE AND A PORTION OF THE CENTRAL LUMEN ABOVE THE TITANIUM RING TO HAVE BEEN MISSING FROM THE DEVICE. A SIGNIFICANT ACCUMULATION OF A DARK RED AND YELLOW, DRIED SUBSTANCE WAS NOTED TO BE ON THE REMAINDER OF THE DEVICE. THE VALVE STRAP WAS NOTED TO HAVE BEEN REMOVED AND NOT RETURNED WITH THE DEVICE. SEVERAL GOUGES WERE NOTED TO BE ON THE KYNAR CARTRIDGE. THE REMAINDER OF THE DEVICE APPEARED INTACT. QUALITY ENGINEERING WAS UNABLE TO TEST DUE TO THE AS-REC'D CONDITION. EXAMINATION OF THE EDGES OF THE MATERIAL SEPARATION REVEALED THE EDGES TO BE JAGGED AND TORN INDICATING THAT THE DEVICE HAD BEEN SUBJECTED TO FORCES AND STRESSES SUFFICIENT TO CAUSE THE MATERIAL SEPARATION. QUALITY ENGINEERING WAS UNABLE TO DETERMINE THE EXACT CAUSE OF THE MATERIAL SEPARATION IN THE DEVICE. NO OTHER ANOMALIES WERE NOTED.

    Description of Event or Problem · 1

    PER INTERVIEW WITH SLP: PATIENT WAS ADMITTED INTO HOSPITAL FOR EXACERBATION OF COPD, IN 2008; WAS EXPERIENCING STRONG COUGHING EPISODES AND VOMITING. ON THE NEXT DAY, THE PT NOTICED THAT THE PROSTHESIS WAS PROTRUDING FROM PUNCTURE SITE; PATIENT REPEATEDLY TRIED TO PUSH DEVICE BACK INTO PLACE. HOSPITAL CONTACTED HER SLP, WHO PROVIDED INSTRUCTION TO STAFF. PROSTHESIS REMAINED IN PUNCTURE SITE (SAFETY STRAP HAD BEEN PREVIOUSLY REMOVED). ON THE FOLLOWING DAY, THE DEVICE WAS NOTICED TO BE MISSING FROM PUNCTURE SITE. THE PATIENT UNDERWENT X-RAY; DEVICE WAS LOCATED IN RIGHT LUNG. A BRONCHOSCOPY WAS PERFORMED. UPON REMOVAL, HOSPITAL STAFF NOTED THAT THE ESOPHAGEAL FLANGE WAS MISSING FROM THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLOM-SINGER VOICE PROSTHESIS EWL HELIX MEDICAL, LLC NA 782851

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention