BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLARYN PLUS

    MDR report key: 4860157 · Received June 19, 2015

    Report

    Report Number
    2135225-2015-00041
    Event Type
    Injury
    Date Received
    June 19, 2015
    Date of Event
    May 13, 2015
    Report Date
    May 21, 2015
    Manufacturer
    MERZ NORTH AMERICA
    Product Code
    KHJ
    PMA / PMN Number
    K013243
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE EMERGENCY ROOM PT HAD A CT SCAN WHICH SHOWED A NODULAR MASS IN THE SUPRAGLOTTIC AREA, SUGGESTING POSSIBLE CALCIUM DEPOSIT. THERE WAS EDEMA AROUND THE MASS. THIS WAS ABOVE THE INJECTION SITE. THE PT HAD NO AIRWAY PROBLEM, BUT HIS MAIN TROUBLE WAS THAT HE COULDN'T "GET ANYTHING DOWN." BECAUSE HE COULDN'T GET ANYTHING DOWN, HE WAS ADMITTED TO THE HOSP AND PUT ON IV STEROIDS AND ANTIBIOTICS. BY (B)(6) 2015, HE WAS SWALLOWING ENOUGH SO THAT HE COULD GO HOME. PHYSICIAN CALLED PT ON (B)(6) 2015 AND HE WAS DOING OKAY. THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED AS THE LOT NUMBER WAS NOT REPORTED.

    Description of Event or Problem · 1

    PHYSICIAN INJECTED PT WITH PROLARYN PLUS FOR LEFT VOCAL CORD PARALYSIS ON (B)(6) 2015. HE INJECTED 0.7 CC TO THE LEFT VOCAL CORD AND THE REMAINDER OF THE SYRINGE TO THE RIGHT VOCAL CORD. TWO DAYS LATER PT WENT TO THE EMERGENCY ROOM COMPLAINING OF DIFFICULTY SWALLOWING, THROAT PAIN, AND A LOW GRADE FEVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400017 PROLARYN PLUS KHJ MERZ NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R ACE INHIBITOR