BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVANESSE VERSA+

    MDR report key: 9654974 · Received January 31, 2020

    Report

    Report Number
    3004423487-2020-00001
    Event Type
    Malfunction
    Date Received
    January 31, 2020
    Date of Event
    January 2, 2020
    Report Date
    January 28, 2020
    Manufacturer
    PROLLENIUM MEDICAL TECHNOLOGY INC.
    Product Code
    LMH
    PMA / PMN Number
    P160042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    1.CORRECTION TO SECTION E1 FROM INITIAL REPORT:- CHANGED THE MDR REPORTER COUNTRY FROM CANADA TO US;(B)(6). 2. CORRECTION TO SECTION E2 FROM INITIAL REPORT:- CHANGED HEALTH PROFESSIONAL TO YES. 3.CORRECTION TO SECTION E3 FROM INITIAL REPORT:-CHANGED OCCUPATION TO PHYSICIAN.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD SUMMARY: THE RETROSPECTIVE REVIEW OF THE BATCH FILE SHOWS THAT NO ELEMENT COULD EXPLAIN THESE ISSUES: THE LOT NUMBER 19D129 WAS VERIFIED AND HAS BEEN CONFIRMED TO BE RELEASED BY THE COMPANY. 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. THE BATCH RECORDS AND TEST REPORTS FROM THIS LOT HAS PASSED ALL TESTS AND A CHECK OF THE NCR HAS PRODUCED ZERO RESULTS FOR THIS LOT NUMBER. THE CHECK ON THE DEVIATION LOG HAS PRODUCED ZERO RESULTS FOR THIS LOT NUMBER AS WELL. THE CERTIFICATE OF ANALYSIS (C OF A) OF THIS LOT SHOWS THAT ALL TESTING PERFORMED ON THE PRODUCT HAS PASSED. RENEW MEDISPA WAS CONTACTED AND THIS ADVERSE EVENT IS UNDER CONSULTATION WITH MEDICAL DIRECTOR.

    Description of Event or Problem · 1

    PATIENT RECEIVED 1 SYRINGE INJECTION IN PERIORAL LINES ON (B)(6) 2019. PATIENT REPORTED SYMPTOMS BY (B)(6) 2019 (INTERMITTENT SWELLING AND DISCOMFORT). HYLENEX TRIED ON (B)(6) 2019 AFTER ONGOING SYMPTOMS WAXING AND WANING. MEDROL PACK TRIED ON (B)(6) 2019. BY EMAIL PATIENT REPORTED SYMPTOMS STILL PERSISTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119135 REVANESSE VERSA+ REVANESSE VERSA+ LMH PROLLENIUM MEDICAL TECHNOLOGY INC. 40082 19D129

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR