BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLARYN GEL

    MDR report key: 22338403 · Received June 26, 2025

    Report

    Report Number
    3013840437-2025-00085
    Event Type
    Malfunction
    Date Received
    June 26, 2025
    Date of Event
    October 10, 2024
    Report Date
    July 2, 2025
    Manufacturer
    MERZ NORTH AMERICA, INC (FRANKSVILLE)
    Product Code
    LMH
    PMA / PMN Number
    K060815
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ASSESSMENT BY MERZ: LOCALIZATION OF THE EVENT WAS NOT PROVIDED BUT LOCAL RELATIONSHIP CAN BE ASSUMED BASED ON THE WORDING OF THIS REPORT. THE REPORTED EVENT OCCURRED IN A COMPATIBLE TEMPORAL RELATIONSHIP. FOREIGN BODY IN SKIN OR SUBCUTANEOUS TISSUE (SERIOUS) IS UNEXPECTED BASED ON CURRENTLY VALID CANADIAN INSTRUCTIONS FOR USE (IFU) LEAFLET OF PROLARYN GEL. THE REPORTED NEEDLE ISSUE IS CONSIDERED REPORTABLE BECAUSE IT COULD HAVE RESULTED IN A SERIOUS ADVERSE EVENT IF IT WERE TO RECUR. NEEDLE ISSUE WAS CODED ONLY FOR FORMAL REASONS. POSSIBLE CONFOUNDING FACTOR INCLUDES THE NEEDLE ISSUE, BUT VERY SPARSE INFORMATION WAS PROVIDED. THEREFORE, CAUSALITY FOR THE EVENT IS ASSESSED AS POSSIBLY RELATED TO THE TREATMENT WITH PROLARYN GEL. THIS CASE IS CONSIDERED REPORTABLE BECAUSE NEEDLE ISSUE BREAKING DURING USE CAN LEAD TO SERIOUS INJURY OR REQUIRE INTERVENTION TO PREVENT SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    ASSESSMENT BY MERZ: LOCALIZATION OF THE EVENT WAS NOT PROVIDED BUT LOCAL RELATIONSHIP CAN BE ASSUMED BASED ON THE WORDING OF THIS REPORT. THE REPORTED EVENT OCCURRED IN A COMPATIBLE TEMPORAL RELATIONSHIP. FOREIGN BODY IN SKIN OR SUBCUTANEOUS TISSUE (SERIOUS) IS UNEXPECTED BASED ON CURRENTLY VALID CANADIAN INSTRUCTIONS FOR USE (IFU) LEAFLET OF PROLARYN GEL. THE REPORTED NEEDLE ISSUE IS CONSIDERED REPORTABLE BECAUSE IT COULD HAVE RESULTED IN A SERIOUS ADVERSE EVENT IF IT WERE TO RECUR. NEEDLE ISSUE WAS CODED ONLY FOR FORMAL REASONS. POSSIBLE CONFOUNDING FACTOR INCLUDES THE NEEDLE ISSUE, BUT VERY SPARSE INFORMATION WAS PROVIDED. THEREFORE, CAUSALITY FOR THE EVENT IS ASSESSED AS POSSIBLY RELATED TO THE TREATMENT WITH PROLARYN GEL. THIS CASE IS CONSIDERED REPORTABLE BECAUSE NEEDLE ISSUE BREAKING DURING USE CAN LEAD TO SERIOUS INJURY OR REQUIRE INTERVENTION TO PREVENT SERIOUS INJURY. MERZ CAUSALITY RE-ASSESSMENT DUE TO AMENDMENT PERFORMED ON 02-JUL-2025: THE LAST SERIOUS SENTENCE REGARDING THE REPORTABLE NEEDLE ISSUE WAS DELETED AND THE SERIOUS SENTENCE FOR THE SERIOUS ADVERSE EVENT FOREIGN BODY IN SKIN OR SUBCUTANEOUS TISSUE WAS ADDED TO THE ADDITIONAL MANUFACTURER NARRATIVE. CAUSALITY FOR THE PREVIOUSLY REPORTED EVENT REMAINS UNCHANGED AS POSSIBLY RELATED TO THE TREATMENT WITH PROLARYN GEL. THIS CASE IS CONSIDERED AS SERIOUS WITH THE SERIOUS EVENT FOREIGN BODY IN SKIN OR SUBCUTANEOUS TISSUE BECAUSE INTERVENTION WAS NECESSARY TO PREVENT A PERMANENT DAMAGE.

    Description of Event or Problem · 0

    CASE DESCRIPTION: THIS SPONTANEOUS REPORT WAS RECEIVED FROM A CANADIAN HEALTH CARE PROFESSIONAL AND CONCERNS A PATIENT. THE PATIENT WAS INJECTED WITH PROLARYN GEL, AS VOCAL INJECTION, ON (B)(6) 2024. THE NEEDLE BROKE OFF FROM THE HUB IN THE MIDDLE OF THE PROCEDURE (NEEDLE ISSUE). ON (B)(6) 2024, AFTER THE PROLARYN GEL INJECTION, THE PATIENT EXPERIENCED A FOREIGN BODY IN SKIN OR SUBCUTANEOUS TISSUE. THE NEEDLE CAME IN PROLARYN KIT. THE OUTCOME OF THE EVENT WAS UNKNOWN.

    Description of Event or Problem · 0

    CASE DESCRIPTION: THIS SPONTANEOUS REPORT WAS RECEIVED FROM A CANADIAN HEALTH CARE PROFESSIONAL AND CONCERNS A PATIENT. THE PATIENT WAS INJECTED WITH PROLARYN GEL, AS VOCAL INJECTION, ON (B)(6) 2024. THE NEEDLE BROKE OFF FROM THE HUB IN THE MIDDLE OF THE PROCEDURE (NEEDLE ISSUE). ON (B)(6) 2024, AFTER THE PROLARYN GEL INJECTION, THE PATIENT EXPERIENCED A FOREIGN BODY IN SKIN OR SUBCUTANEOUS TISSUE. THE NEEDLE CAME IN PROLARYN KIT. THE OUTCOME OF THE EVENT WAS UNKNOWN. AMENDMENT WAS PERFORMED ON 01JUL2025: AMENDMENT WAS PERFORMED FOR THIS CASE TO CORRECT THE ASSESSMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1883756 PROLARYN GEL IMPLANT, DERMAL, FOR AESTHETIC USE LMH MERZ NORTH AMERICA, INC (FRANKSVILLE)

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R