BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHA REDENSITY

    MDR report key: 20520620 · Received October 24, 2024

    Report

    Report Number
    3007772056-2024-00021
    Event Type
    Injury
    Date Received
    October 24, 2024
    Date of Event
    October 1, 2024
    Report Date
    October 29, 2024
    Manufacturer
    TEOXANE
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    UNILATERAL PALSY [FACIAL PARALYSIS]. SWELLING [SWELLING]. CASE NARRATIVE: UNITED STATES REPORT RECEIVED FROM A PHYSICIAN VIA COMPANY REPRESENTATIVE ON (B)(6)2024 AND REFERS TO A FEMALE PATIENT OF AN UNKNOWN AGE WHO HAS RECEIVED RHA REDENSITY FOR AN UNKNOWN INDICATION IN 2024. THE PATIENT'S MEDICAL HISTORY INCLUDED FALL/INJURY WHEN SHE WAS YOUNG. THE PATIENT'S PAST COSMETIC HISTORY INCLUDED RHA REDENSITY INJECTION ON LIPS VIA NEEDLE TECHNIQUE (IN 2024), AFTER WHICH THE PATIENT EXPERIENCED SOME SWELLING AND UNILATERAL PALSY (CAPTURED IN LINKED CASE (B)(4)). CONCOMITANT MEDICATIONS AND FOOD SUPPLEMENTS WERE NOT PROVIDED. AN UNKNOWN VOLUME OF RHA REDENSITY WAS APPLIED ON AN UNKNOWN INJECTION SITE VIA AN UNKNOWN TECHNIQUE. IT WAS NOT REPORTED IF CANNULA WAS USED FOR THE ADMINISTRATION. ON AN UNKNOWN DATE IN 2024, AFTER THE SECOND TREATMENT WITH RHA REDENSITY, THE PATIENT EXPERIENCED UNILATERAL PALSY. THE PATIENT ALSO EXPERIENCED SWELLING, WHICH MIGHT HAVE CONTRIBUTED TO THE NERVE COMPRESSION THAT CAUSED THE PALSY. BASED ON THE PATIENT'S MEDICAL HISTORY THE HCP WAS NOT SURE IF THERE WAS SOME CERVICAL INTERACTION. AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENTS OF UNILATERAL PALSY AND SWELLING WAS UNKNOWN. THE INTENSITY OF THE EVENTS WAS NOT REPORTED. IT WAS UNKNOWN IF THE PRODUCT WAS AVAILABLE FOR RETURN. HEALTH EFFECT: CLINICAL CODE E012209, FACIAL PARALYSIS. HEALTH EFFECT: CLINICAL CODE E2338, SWELLING/ EDEMA. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. THIS CASE IS LINKED WITH (B)(4) (SAME PATIENT). COMPANY COMMENT: THE RELATIONSHIP BETWEEN RHA REDENSITY AND THE REPORTED FACIAL PALSY IS ASSESSED AS POSSIBLY RELATED CONSIDERING PLAUSIBLE TIMELINES. THE COMPANY WILL CONTINUE MONITORING THE BENEFIT-RISK PROFILE FOR THE PRODUCT.

    Description of Event or Problem · 0

    UNILATERAL PALSY/ L SIDE FACIAL PALSY [FACIAL PARALYSIS] SWELLING/ UNILATERAL FACIAL SWELLING/ SWELLING WAS MORE PERIOCULAR [SWELLING FACE] ARM WEAKNESS [MUSCULAR WEAKNESS] RHA REDENSITY IN BOTTOM LIP ONLY [OFF LABEL USE]. CASE NARRATIVE: UNITED STATES REPORT RECEIVED FROM A PHYSICIAN VIA COMPANY REPRESENTATIVE ON (B)(6)2024 AND REFERS TO A FEMALE PATIENT OF AN UNKNOWN AGE WHO HAS RECEIVED RHA REDENSITY FOR AN UNKNOWN INDICATION IN (B)(6)2024. THE PATIENT'S MEDICAL HISTORY INCLUDED FALL/INJURY. WHEN A TEENAGER HAD SOME INJURY THAT CAUSED SOME SPINAL STENOSIS AND L WEAKNESS, THE PATIENT WAS UNSURE OF THE DETAILS. THE PATIENT'S PAST COSMETIC HISTORY INCLUDED RHA REDENSITY INJECTION ON LIPS VIA NEEDLE TECHNIQUE (IN 2024), AFTER WHICH THE PATIENT EXPERIENCED SOME SWELLING, UNILATERAL PALSY AND ARM WEAKNESS (CAPTURED IN LINKED (B)(4)). ON AN UNKNOWN DATE, SHE ALSO HAD RESTYLANE (HYALURONIC ACID) APPLIED IN HER LIPS WITHOUT ISSUE, AS REPORTED. CONCOMITANT MEDICATIONS AND FOOD SUPPLEMENTS WERE NOT PROVIDED. AN UNKNOWN VOLUME OF RHA REDENSITY WAS APPLIED TO THE BOTTOM LIP VIA AN UNKNOWN TECHNIQUE. IT WAS NOT REPORTED IF CANNULA WAS USED FOR THE ADMINISTRATION. ON AN UNKNOWN DATE IN (B)(6)2024 (REPORTED AS AROUND 1 WEEK AFTER FILLER PLACEMENT), AFTER THE SECOND TREATMENT WITH RHA REDENSITY, THE PATIENT EXPERIENCED UNILATERAL PALSY, LEFT SIDE, AND PERIOCULAR SWELLING. ALSO HAD ARM WEAKNESS. SHE TOOK TREATMENT WITH STEROIDS, AND SHE WAS RECOVERING. THE PATIENT HAD SEEN A NEUROLOGIST, WITH NO DIAGNOSIS KNOWN TO THE TREATING HCP. THE PATIENT UNDERWENT MAGNETIC RESONANCE IMAGING (MRI) AND COMPUTED TOMOGRAPHY (CT) SCANS, BOTH OF WHICH SHOWED UNREMARKABLE RESULTS. AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENTS OF UNILATERAL PALSY, SWELLING WAS MORE PERIOCULAR, AND ARM WEAKNESS WAS RESOLVING. THE INTENSITY OF THE EVENTS WAS NOT REPORTED. IT WAS UNKNOWN IF THE PRODUCT WAS AVAILABLE FOR RETURN. HEALTH EFFECT: CLINICAL CODE E012209, FACIAL PARALYSIS. HEALTH EFFECT: CLINICAL CODE E2338, SWELLING/ EDEMA. HEALTH EFFECT: CLINICAL CODE E1621, MUSCLE WEAKNESS/ATROPHY. HEALTH EFFECT: DEVICE CODE A2304, OFF-LABEL USE. THIS CASE IS LINKED WITH (B)(4) (SAME PATIENT). FOLLOW UP RECEIVED FROM A PHYSICIAN VIA COMPANY REPRESENTATIVE ON (B)(6)2024 INCLUDED MORE PRECISE DAY OF INJECTION SECOND TREATMENT (ABOUT 2 WEEKS AGO), INJECTION SITE (BOTTOM LIP), NEW EVENT (ARM WEAKNESS), BETTER DESCRIPTION ABOUT EVENT UNILATERAL PALSY (IT WAS ON LEFT SIDE) AND EVENT SWELLING (IT WAS MORE PERIOCULAR), DIAGNOSTIC PROCEDURES (MRI AND CT SCAN) AND NEUROLOGICAL EXAM, CHANGE OUTCOME FROM UNKNOWN TO RECOVERING, TREATMENT OF EVENTS, MORE DETAILED MEDICAL HISTORY ABOUT INJURY WHEN SHE WAS TEENAGER, AND NEW COSMETIC PROCEDURE IN THE PAST (RESTYLANE). COMPANY COMMENT: THE RELATIONSHIP BETWEEN RHA REDENSITY AND THE REPORTED FACIAL PALSY ON THE LEFT IS ASSESSED AS POSSIBLY RELATED CONSIDERING PLAUSIBLE TIMELINES. THE COMPANY WILL CONTINUE MONITORING THE BENEFIT-RISK PROFILE FOR THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1424874 RHA REDENSITY RESILIENT HYALURONIC ACID LMH TEOXANE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention