BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVANESSE VERSA

    MDR report key: 8785460 · Received July 12, 2019

    Report

    Report Number
    3004423487-2019-00004
    Event Type
    Malfunction
    Date Received
    July 12, 2019
    Date of Event
    June 20, 2018
    Report Date
    August 15, 2018
    Manufacturer
    PROLLENIUM MEDICAL TECHNOLOGIES INC
    Product Code
    LMH
    PMA / PMN Number
    P160042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS VERIFIED AND HAS BEEN CONFIRMED TO BE RELEASED BY THE COMPANY. IT HAS BEEN CONFIRMED THAT NO PREVIOUS CLINICAL COMPLAINTS HAVE BEEN FOUND FOR THE PARTICULAR LOT NUMBER IN QUESTION. THE BATCH RECORD, QC TEST REPORTS, AND TRAINING OF STAFF WERE ANALYZED AND IT HAS BEEN DETERMINED THAT PRODUCT IS WITHIN REQUIRED SPECIFICATIONS, AND MANUFACTURED ACCORDING TO THE APPROPRIATE PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    PATIENT - ((B)(6)): (B)(6) 2018; RECEIVED 1ML SYRINGE OF VERSA MIXED WITH 0.1ML OF 1% LIDOCAINE IN NASAL LABIAL FOLDS AND LIPS. NURSE USED 27G 0.5IN NEEDLE TO INJECT WITH A BOLUS AND RETROGRADE INJECTION TECHNIQUE. (B)(6) NOTICED LARGE BUMP IN RIGHT UPPER LIP FORMING WITHIN 48-72 HRS POST INJECTION THAT WAS NOT AS NOTICEABLE OR SEVERE IMMEDIATELY AFTER TREATMENT. ADVISED TO WAIT 2 WEEKS FOR SIDE EFFECTS TO SUBSIDE. ON (B)(6) 2018; (B)(6) INJECTED WITH 0.1ML OF HYALURONIDASE TO LARGE APPEARING BUMP IN RIGHT UPPER LIP. NO BUMP WAS ABLE TO BE LOCALIZED; JUST SEEMINGLY SWOLLEN TISSUE IN THE AREA. ON (B)(6) 2018; BUMP IN RIGHT UPPER LIP APPEARS TO BE SLIGHTLY REDUCED YET STILL LARGER THAN LEFT UPPER LIP AND WITH SWELLING. 0.2ML OF HYALURONIDASE INJECTED IN AREA. ON (B)(6) 2018; BUMP IN RIGHT UPPER LIP STILL LARGER THAN LEFT UPPER LIP AND SWOLLEN AFTER 2 HYALURONIDASE INJECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581027 REVANESSE VERSA REVANESSE VERSA LMH PROLLENIUM MEDICAL TECHNOLOGIES INC PN40081 17K004

    Patients

    Seq Age Sex Outcome Treatment
    1