BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7572192 · Received June 5, 2018

    Report

    Report Number
    2210968-2018-73320
    Event Type
    Injury
    Date Received
    June 5, 2018
    Report Date
    May 28, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE ENTITLED: RETAINED TRACHEOTOMY SUTURE: NINE YEARS OF MORBIDITY AUTHORS: DARNELL J. BROWN, AND MICHAEL J. PITMAN, MD, VALHALLA AND NEW YORK, NY CITATION: OTOLARYNGOLOGY¿HEAD AND NECK SURGERY (2010) 142, 626-627; DOI:10.1016/J.OTOHNS.2009.11.022. THIS CLINICAL PHOTOGRAPH INVOLVED A (B)(6)-YEAR-OLD MALE WHO PRESENTED WITH THROAT IRRITATION, COUGH, AND DYSPHONIA SINCE A MOTOR VEHICLE ACCIDENT NINE YEARS PREVIOUSLY. AT THAT TIME, THE PATIENT EXPERIENCED A TRAUMATIC BRAIN INJURY (TBI) AND REQUIRED LONG-TERM VENTILATION. AFTER 1.5 WEEKS OF OROTRACHEAL INTUBATION, A TRACHEOTOMY WAS PERFORMED. WHEN THE AUTHORS EXAMINED THE PATIENT, IN-OFFICE TRANS-NASAL LARYNGOSCOPY REVEALED A NORMAL LARYNX WITH A FIRM WHITE STRAND EMANATING FROM THE TRACHEA AND EXTENDING THROUGH THE GLOTTIS. THE PATIENT WAS BROUGHT TO THE OPERATING ROOM FOR A DIRECT LARYNGOSCOPY. THE FOREIGN BODY WAS NOTED TO BE A RETAINED PROLENE SUTURE ATTACHED TO THE OLD TRACHEOTOMY SITE. THE SUTURE WAS TRANSECTED AND REMOVED. POSTOPERATIVELY, THE PATIENT¿S COUGH AND LARYNGEAL IRRITATION RESOLVED. HOWEVER, HIS DYSPHONIA PERSISTED BECAUSE IT WAS DUE TO THE TBI, NOT GLOTTAL INFLAMMATION. THE AUTHORS NOTED THAT TRACTION SUTURE WAS LIKELY PLACED IN THE TRACHEA DURING THIS PATIENT¿S TRACHEOTOMY, OR A BJORK FLAP WAS PERFORMED, BUT INFORMATION WAS NOT PRESENT TO CONFIRM THIS. A PROLENE SUTURE WAS LIKELY USED AS A TRACTION SUTURE OR TO SECURE A BJORK FLAP. UNFORTUNATELY, THE SUTURE WAS NEVER REMOVED, RESULTING IN NINE YEARS OF MORBIDITY. THIS COMPLICATION HIGHLIGHTS THE BENEFIT OF USING RESORBABLE SUTURES, SUCH AS VICRYL SUTURES DURING A TRACHEOTOMY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411771 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention