BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLARYN PLUS INJECTABLE IMPLANT

    MDR report key: 7213370 · Received January 23, 2018

    Report

    Report Number
    2135225-2018-00001
    Event Type
    Injury
    Date Received
    January 23, 2018
    Report Date
    February 27, 2018
    Manufacturer
    MERZ NORTH AMERICA
    Product Code
    KHJ
    PMA / PMN Number
    K013243
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    FOLLOW UP INFORMATION WAS RECEIVED ON 21-FEBRUARY-2018: AFTER A CLOSE CONSULTATION WITH THE INVESTIGATING SURGEON, IT WAS CONCLUDED THAT THIS INCIDENT WAS NOT A FAULT OF THE INJECTABLE DEVICE PROLARYN PLUS. THE INVESTIGATION CONCERNED A SURGEON'S TECHNIQUE INVOLVING VOCAL CORD INJECTION, USING PROLARYN PLUS AS THE INJECTABLE AGENT. UNDER NO CIRCUMSTANCES WERE THE INCIDENT AND THE INVESTIGATION EVER TO DO WITH IDENTIFYING FAULT WITH PROLARYN PLUS. ANY ADVERSE EFFECTS THAT WERE REPORTED FROM THE INVESTIGATION WERE ONLY TO DO WITH THE CONSEQUENCES OF THE SURGICAL TECHNIQUE THAT ALSO WENT BEYOND THE SCOPE OF INJECTING PROLARYN PLUS.

    Additional Manufacturer Narrative · 1

    THE CASE WAS ASSESSED AS REPORTABLE TO THE FDA. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED FROM A SOUTH AFRICAN PHYSICIAN AND CONCERNS A PATIENT. THE PATIENT WAS INJECTED WITH PROLARYN® PLUS INTO THE VOCAL CORD. THE SURGEON MAY HAVE OVER DELIVERED PROLARYN® PLUS INTO A VOCAL CORD AND INQUIRED RECOMMENDATIONS REGARDING THE PROCEDURE FOR SURGICAL RETRIEVAL OF THE EXCESS OF PRODUCT. FOLLOW-UP INFORMATION WAS RECEIVED ON 15-JAN-2018: THE CASE WAS UPGRADED TO SERIOUS. THE EVENTS "FOREIGN MATERIAL WITH SURROUNDING FIBROSIS" AND "MINIMAL FOREIGN BODY GRANULOMATOUS REACTION" WERE ADDED. EVENT TERM "DELIVERED PROLARYN® PLUS INTO A VOCAL CORD" WAS CHANGED TO "DELIVERED PROLARYN® PLUS INTO A VOCAL CORD/OVER INJECTED/POSSIBLY OVERFULL" AND THIS EVENT WAS CONSIDERED SERIOUS. THE CASE CONCERNS A FEMALE PATIENT. SHE WAS INJECTED WITH PROLARYN® PLUS LATERAL TO THE VOCAL FOLD TO IMPROVE VOICE. IN THE OPINION OF A SURGEON, THE PRODUCT WAS INCORRECTLY AND OVER-INJECTED, POSSIBLY OVERFULL AND A BIT SUPERFICIAL. THE PATIENT'S MEDICAL HISTORY INCLUDED LEFT VOCAL FOLD PALSY. A FEW HOURS AFTER THE TREATMENT WITH PROLARYN® PLUS, THE PATIENT HAD A REACTION BUT WENT HOME THE SAME DAY. AT FOUR MONTHS POST INJECTION, THE SECOND SURGEON TRIED TO RESECT PROLARYN® PLUS VIA A LATERAL (THYROIDECTOMY) APPROACH. HE STATED THAT THE PATIENT HAD FIBROSIS AND HER VOICE WAS ALWAYS GOING TO BE HOARSE. THEREFORE, THE OUTCOME OF THIS EVENT WAS DEEMED NOT RECOVERED. THE HISTOLOGY SHOWED FRAGMENTS OF VOLUNTARY MUSCLE WITH FOCUSES OF FOREIGN MATERIAL WITH SURROUNDING FIBROSIS AND MINIMAL FOREIGN BODY GRANULOMATOUS REACTION. THAT WAS SUMMARIZED AS VOLUNTARY MUSCLE WITH FOCAL DEPOSITS OF PARTIALLY CALCIFIED FOREIGN MATERIAL. IN THE OPINION OF THE REPORTER, THE EVENT OF "MINIMAL FOREIGN BODY GRANULOMATOUS REACTION" WAS OF MILD INTENSITY.

    Description of Event or Problem · 1

    FOLLOW-UP INFORMATION WAS RECEIVED ON 05-FEB-2018: THE PATIENT'S PAST MEDICAL HISTORY INCLUDED A THYROIDECTOMY. THE REPORTER INFORMED THAT HE WAS A THIRD PARTY ASKED FOR ADVICE AND THAT HE DID NOT SEE THE PATIENT. HE CONFIRMED HE SAW ONLY A PHOTOGRAPH OF THE PATIENT AND NOTED A MILD OVER CORRECTION. DUE TO THE PROVIDED INFORMATION, THE INTENSITY OF THE EVENT "DELIVERED PROLARYN PLUS INTO A VOCAL CORD/OVER INJECTED/POSSIBLY OVERFULL" WAS ADDED AS MILD. AS PER REPORTER, THERE WAS NO ADVERSE EVENT AND THERE WERE NO PROBLEMS ASSOCIATED WITH PROLARYN PLUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55434 PROLARYN PLUS INJECTABLE IMPLANT POLYMER, ENT SYNTHETIC POLYAMIDE KHJ MERZ NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability