BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLARYN GEL

    MDR report key: 5728789 · Received June 16, 2016

    Report

    Report Number
    2135225-2016-00015
    Event Type
    Injury
    Date Received
    June 16, 2016
    Date of Event
    May 19, 2016
    Report Date
    July 6, 2016
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    MIX
    PMA / PMN Number
    K060815
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR PROLARYN GEL LOT 100088620 WAS REVIEWED.

    Additional Manufacturer Narrative · 1

    THIS CASE WAS ASSESSED AS REPORTABLE TO THE FDA AS THE ADVERSE EVENT, POSSIBLE ALLERGIC REACTION REQUIRING INTUBATION, WAS DEEMED TO MEET SERIOUS INJURY CRITERIA OF REQUIRING MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. THE DEVICE HISTORY RECORD FOR RADIESSE DERMAL FILLER LOT 100088620 WAS REVIEWED. NO NONCONFORMANCES WERE NOTED THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. A LOT SEARCH WAS CONDUCTED ON THE REPORTED LOT AND NO SIMILAR EVENTS WERE NOTED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS GATHERED FROM MEDWATCH REPORT MW5062519, WHICH WAS RECEIVED ON 06-JUL-2016. THE PATIENT DEVELOPED RESPIRATORY DISTRESS REQUIRING INTUBATION 24 HOURS FOLLOWING INJECTION WITH PROLARYN GEL TO THE INTERARYTENOID SPACE. PATIENT WAS INTUBATED FOR FOUR DAYS AND EVENTUALLY EXTUBATED WITHOUT COMPLICATION. THE ROUTE OF ADMINISTRATION WAS SUBMUCOUS. THE INDICATION FOR USE WAS PHARYNGEAL DYSPLASIA.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THAT A (B)(6) MALE PATIENT WAS INJECTED WITH PROLARYN. ON (B)(6) 2016, PATIENT WAS INJECTED WITH AN UNSPECIFIED AMOUNT OF PROLARYN TO AN UNSPECIFIED AREA. ON (B)(6) 2016, PATIENT DEVELOPED INCREASED BREATHING, A FEVER OF 102, AND VOICE CHANGES. TREATMENT REPORTED AS INTUBATION. ON 24-MAY-2016, FOLLOW UP INFORMATION WAS RECEIVED FROM THE PHYSICIAN. PATIENT HAD NO VOCAL FOLD PARESIS, PARALYSIS, OR ATROPHY. PATIENT WAS INJECTED TO THE INTERARYTENOID SPACE WITH AN UNSPECIFIED AMOUNT OF PROLARYN GEL FOR DYSPHAGIA. ON 06-JUN-2016, FOLLOW UP INFORMATION WAS RECEIVED FROM THE PHYSICIAN. PATIENT WAS INJECTED WITH 0.3ML OF PROLARYN GEL AND EXPERIENCED A POSSIBLE ALLERGIC REACTION. ON AN UNSPECIFIED DATE, PATIENT WAS INTUBATED TO PROTECT THE AIRWAY. FIVE DAYS LATER, HE WAS EXTUBATED. MEDICAL HISTORY POSITIVE FOR CHRONIC DYSPHAGIA AND ASPIRATION. CONCOMITANT MEDICATIONS AND RELEVANT MEDICAL HISTORY REPORTED AS NONE. LOT NUMBER REPORTED AS 100088620. CAUSALITY REPORTED AS POSSIBLY RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383536 PROLARYN GEL INJECTABLE IMPLANT MIX MERZ NORTH AMERICA, INC. 100088620

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention