BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVANESSE LIPS+(WITH LIDOCAINE) 1.2 ML

    MDR report key: 18156812 · Received November 16, 2023

    Report

    Report Number
    3004423487-2023-00041
    Event Type
    Injury
    Date Received
    November 16, 2023
    Report Date
    November 20, 2023
    Manufacturer
    PROLLENIUM MEDICAL TECHNOLOGIES INC.
    Product Code
    LMH
    UDI-DI
    10669808003032
    PMA / PMN Number
    P160042 S014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MORE INFORMATION HAS BEEN REQUESTED FROM THE CLINIC A COUPLE OF TIME. HOWEVER, NO MORE INFORMATION (EXCEPT CORRECT LOT NUMBER) HAS BEEN PROVIDED BY THE CLINIC. THE RETROSPECTIVE REVIEW OF THE BATCH FILE SHOWS THAT NO ELEMENT COULD EXPLAIN THESE ISSUES. DUE TO THE LACK OF CLINICAL INFORMATION PROVIDED BY THE CLINIC, IT IS NOT POSSIBLE FOR PROLLENIUM MEDICAL DIRECTOR TO GIVE A MEANINGFUL CLINICAL OPINION.

    Additional Manufacturer Narrative · 0

    MORE INFORMATION HAS BEEN REQUESTED FROM THE CLINIC A COUPLE OF TIME. HOWEVER, NO MORE INFORMATION (REGARDING PATIENT BACKGROUND ,CLINIC,TREATMENT INFORMATION, IMAGES OF AE) HAS BEEN PROVIDED BY THE CLINIC. SINCE THE WRONG LOT NUMBER HAS BEEN PROVIDED BY THE CLINIC AND THE LACK OF FURTHER REQUESTED INFORMATION, IT WAS NOT POSSIBLE FOR PROLLENIUM TO COMPLETE INTERNAL INVESTIGATION.

    Description of Event or Problem · 0

    FOLLOW UP REPORT: 3004423487-2023-00041. BASED ON THE INFORMATION/REPORT PROVIDED BY THE CLINIC, A 25 YO FEMALE, WAS INJECTED WITH 1.2 ML REVANESSE LIPS+ (WITH LIDOCAINE) IN LIPS ON (B)(6) 2023. THE PATIENT GOT A COLD (THE DURATION BETWEEN THE TREATMENT DATE AND EVENT DATE WAS NOT DISCLOSED) AND LIPS PROGRESSIVELY GOT MORE SWOLLEN. MORE INFORMATION HAS BEEN REQUESTED FROM THE CLINIC A COUPLE OF TIMES ON (B)(6) 2023). HOWEVER, NO MORE INFORMATION (ASSOCIATED WITH THE REPORTED AE, PATIENT BACKGROUND, CLINIC, TREATMENT INFORMATION, IMAGES) HAS BEEN PROVIDED BY THE CLINIC. THE PROVIDED LOT NUMBER WAS WRONG (F22I037). THE ONLY NEW INFORMATION HAS BEEN PROVIDED BY THE CLINIC IS THE CORRECT LOT NUMBER: (23E084). THE LOT NUMBER: 23E084 WAS VERIFIED AND IT IS CORRECT. IT HAS BEEN RELEASED BY PROLLENIUM MEDICAL TECHNOLOGIES INC. THE BATCH RECORD, QC TEST REPORTS (18-MAY-2023), AND QC FINAL INSPECTION REVIEW CHECK LIST (02-JUN-2023) WERE ANALYZED 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 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. THE CERTIFICATE OF ANALYSIS (COA) OF THIS LOT SHOWS THAT ALL TESTING PERFORMED ON THE PRODUCT HAS PASSED. THE INFORMATION PROVIDED BY THE CLINIC HAS BEEN SUBMITTED TO THE PROLLENIUM MEDICAL DIRECTOR FOR REVIEW. THE MEDICAL DIRECTOR'S OPINION ABOUT THE REPORTED AE IS AS FOLLOWS: "THE FOLLOWING IS A CLINICAL OPINION BASED ON THE INFORMATION PROVIDED IN CASE: (B)(4). ON AN UNSPECIFIED DATE ON (B)(6) 2023, A PATIENT RECEIVED 1.2 CC OF REVANESSE LIPS+ INTO THEIR LIPS. ON AN UNSPECIFIED LATER DATE THE PATIENT " GOT A COLD AND LIPS PROGRESSIVELY GOT MORE SWOLLEN". NO FURTHER HISTORY WAS PROVIDED. THERE IS NO PAST MEDICAL HISTORY SUCH AS MEDICAL CONDITIONS, MEDICATIONS OR HISTORY OF COLD SORES OR VACCINES. NO POST ASSESSMENT OR PRE & POST TREATMENT PLANS WERE PROVIDED. NO PRE OR POST PHOTOS WERE PROVIDED. ONLY 12 OF THE REQUIRED 31 INTAKE QUESTIONS WERE ANSWERED. THE LOT NUMBER PROVIDED BY THE INJECTOR DOES NOT EXIST IN THE PROLLENIUM INVENTORY SYSTEM. DUE TO THE LACK OF CLINICAL INFORMATION PROVIDED BY THE CLINIC, IT IS NOT POSSIBLE TO GIVE A MEANINGFUL CLINICAL OPINION ON THIS CASE. INTERNAL PROLLENIUM COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 0

    BASED ON THE INFORMATION/REPORT PROVIDED BY THE CLINIC, A 25 YO FEMALE, WAS INJECTED WITH 1.2 ML REVANESSE LIPS+ (WITH LIDOCAINE) (WRONG LOT NUMBER WAS PROVIDED) IN LIPS ON (B)(6) 2023. THE PATIENT GOT A COLD (THE DURATION BETWEEN THE TREATMENT DATE AND EVENT DATE WAS NOT DISCLOSED) AND LIPS PROGRESSIVELY GOT MORE SWOLLEN. MORE INFORMATION HAS BEEN REQUESTED FROM THE CLINIC A COUPLE OF TIMES ((B)(6) 2023). HOWEVER, NO MORE INFORMATION (ASSOCIATED WITH THE REPORTED AE, PATIENT BACKGROUND,CLINIC ,TREATMENT INFORMATION, IMAGES) HAS BEEN PROVIDED BY THE CLINIC. SINCE THE WRONG LOT NUMBER HAS BEEN PROVIDED BY THE CLINIC AND NO FURTHER REQUESTED INFORMATION AND IMAGES HAVE BEEN PROVIDED BY THE CLINIC, IT WAS NOT POSSIBLE FOR PROLLENIUM TO COMPLETE INTERNAL INVESTIGATION. THE INFORMATION PROVIDED BY THE CLINIC HAS BEEN SUBMITTED TO THE PROLLENIUM MEDICAL DIRECTOR FOR REVIEW. THE MEDICAL DIRECTOR'S OPINION ABOUT THE REPORTED AE WILL BE SUBMITTED IN THE FOLLOW UP REPORT. INTERNAL PROLLENIUM COMPLAINT NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    981143 REVANESSE LIPS+(WITH LIDOCAINE) 1.2 ML REVANESSE LIPS+(WITH LIDOCAINE) 1.2 ML LMH PROLLENIUM MEDICAL TECHNOLOGIES INC. PN40149 23E084 10669808003032

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female Other