BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOT CONFIRMED BY CLINIC

    MDR report key: 16587438 · Received March 21, 2023

    Report

    Report Number
    3004423487-2023-00002
    Event Type
    Injury
    Date Received
    March 21, 2023
    Date of Event
    February 19, 2023
    Report Date
    February 22, 2023
    Manufacturer
    PROLLENIUM MEDICAL TECHNOLOGIES INC.
    Product Code
    LMH
    PMA / PMN Number
    P160042 S003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO INFORMATION WAS PROVIDED ON THE PRODUCT IN QUESTION NOR ASSOCIATED LOT. BASED ON THE INFORMATION PROVIDED BY PMT SALES DEPT, THE FOLLOWING LOTS HAVE BEEN SOLD TO NATURE MED SPA.· 22G091· 22G122· 22C034· 22E082. THE PRODUCT LOT NUMBER HAS BEEN VERIFIED AND HAS BEEN CONFIRMED TO BE RELEASED BY THE COMPANY. THE BATCH RECORD, QC TEST REPORTS, AND TRAINING OF STAFF WERE ANALYSED AND IT HAS BEEN DETERMINED THAT PRODUCT IS WITHIN REQUIRED SPECIFICATIONS AND MANUFACTURED ACCORDING TO APPROPRIATE PROCEDURES. THE BATCH RECORD, QC TEST REPORTS AND QC FINAL INSPECTION REVIEW CHECK LIST WERE ANALYSED, AND IT HAS BEEN DETERMINED THAT THE PRODUCT WAS RELEASED WITHIN FINAL RELEASE SPECIFICATIONS. THE RETROSPECTIVE REVIEW OF THE BATCH FILE SHOWS THAT NO ELEMENT COULD EXPLAIN THESE ISSUES. THE LOT NUMBER 22G091,22G122,22C034 & 22E082 WAS VERIFIED AND HAS BEEN CONFIRMED TO BE RELEASED BY THE COMPANY. THE BATCH RECORD, QC TEST REPORTS, AND TRAINING OF STAFF WERE ANALYSED, AND IT HAD BEEN DETERMINED THAT PRODUCT IS WITHIN REQUIRED SPECIFICATIONS AND MANUFACTURED ACCORDING TO THE APPROPRIATE PROCEDURES. THE BATCH RECORDS AND REST OF THE REPORTS FOR THIS LOT HAD PASSED ALL TESTS AND A CHECK OF THE NCR LOG FOR THIS LOT NUMBER HAS PRODUCED ZERO RESULTS FOR THIS LOT NUMBER. THE CHECK ON THE DEVIATION LOG HAD PRODUCED ZERO RESULTS FOR THIS LOT NUMBER AS WELL.

    Description of Event or Problem · 0

    ADVERSE EVENT INFORMATION: BASED ON THE INFORMATION PROVIDED BY THE CLINIC, ON (B)(6) 2023 THE PATIENT WAS INJECTED ON THE LIPS WITH 3/4 OF THE VERSA PRODUCT. NO INFORMATION WAS PROVIDED ON THE PRODUCT IN QUESTION NOR ASSOCIATED LOT. THE CLINIC REPORTS THAT 30 MINUTES POST INJECTION, THE PATIENTS' LIPS STARTED TO BLANCH. THE CLINIC IMMEDIATELY PUT THE OCCLUSION PROTOCOL IN PLACE TO DISSOLVE THE FILLER. CLINIC REPORTS THAT THE PATIENT HAS NOT REACHED BACK TO THE CLINIC ONCE THE TREATMENT WAS COMPLETED. THE PATIENT IS BETTER. NO INFORMATION WAS PROVIDED ON THE USE OF TOPICAL ANAESTHETICS OR MEDICATIONS BEFORE TREATMENT. NO BEFORE OR AFTER PHOTOGRAPHS WHERE PROVIDED. THE MANUFACTURER INITIATED THE INVESTIGATION BY CONDUCTING A REVIEW OF ITS INTERNAL RECORDS ASSOCIATED WITH THE BATCH. IN ADDITION, A REVIEW FROM THE COMPANY'S MEDICAL DIRECTOR WAS SOUGHT. PROLLENIUM MEDICAL TECHNOLOGIES INC. HAS CONSULTED ITS MEDICAL DIRECTOR AND HIS RESPONSE TO THE INCIDENT IS DETAILED BELOW. "THE FOLLOWING IS CLINICAL OPINION BASED ON THE LIMITED INFORMATION PROVIDED BY THE TREATING CLINIC RE; CASE (B)(4).ON (B)(6) 2023, A PATIENT HAD 3/4 OF A SYRINGE OF REVANESSE VERSA LIPS INJECTED INTO HER LIPS. THE LIPS APPEARED "BLANCHED" AT WHICH TIME THE INJECTOR INITIATED THEIR "OCCLUSION" PROTOCOL. THE CLINICAL EVENT RESOLVED, AND THE PATIENT WAS NOT SEEN AFTER. NO PHOTOS WERE PROVIDED. MY CLINICAL OPINION IS THAT THIS WAS A CASE OF VASCULAR OCCLUSION WHICH WAS SUCCESSFULLY TREATED" OCCLUSION IS ALWAYS INJECTOR ERROR EVEN THOUGH IT IS UNINTENTIONAL. THIS IS NOT A PRODUCT PROBLEM BUT RATHER AN UNINTENTIONAL MISUSE OR ERROR BY THE INJECTOR". BASED ON THE OPINION OF THE MEDICAL DIRECTOR, THE ADVERSE INCIDENT IS A VASCULAR OCCLUSION THAT WAS TREATED SUCCESSFUL WITH THE PROTOCOLS INITIATED AT THE USER FACILITY. THIS IS NOT A PRODUCT PROBLEM BUT RATHER AN UNINTENTIONAL MISUSE OR ERROR BY THE INJECTOR. PATIENT WAS TREATED AND IS FINE.THE CLINIC HAS NOT BEEN COMPLAINT WITH PMT IN PROVIDING REQUESTED INFORMATION REQUIRED FOR REPORTING OF THE PRODUCT INFORMATION. PROLLENIUM WILL BE CONCLUDING ITS INVESTIGATIONS AND CLOSING THIS REPORT. INTERNAL REPORT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11857 NOT CONFIRMED BY CLINIC NOT CONFIRMED BY CLINIC LMH PROLLENIUM MEDICAL TECHNOLOGIES INC. NOT CONFIRMED BY CLINIC NOT CONFIRMED BY CLINIC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention