BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE DEFYNE

    MDR report key: 17139635 · Received June 15, 2023

    Report

    Report Number
    9710154-2023-00042
    Event Type
    Injury
    Date Received
    June 15, 2023
    Date of Event
    May 1, 2023
    Report Date
    July 7, 2023
    Manufacturer
    Q-MED
    Product Code
    LMH
    PMA / PMN Number
    P140029/S045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPANY COMMENT: THE SERIOUS EVENTS OF SWELLING, MASS AT IMPLANT SITE AND THE NON-SERIOUS EVENTS OF INDURATION, BRUISING, HAEMATOMA AT IMPLANT SITE AND DISCOMFORT AT INJECTION SITE WERE CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENTS. SERIOUSNESS CRITERIA INCLUDE THE NEED FOR MULTIPLE MEDICAL INTERVENTIONS TO PREVENT PERMANENT DAMAGE. THE POTENTIAL ROOT CAUSE IS THE TREATMENT PROCEDURE. POTENTIAL CONTRIBUTORY FACTOR INCLUDES INJECTION TECHNIQUE AND PREVIOUS COSMETIC PROCEDURE OF ULTHERAPY. INTENTIONAL DEVICE MISUSE WAS REPORTED AS THE RESTYLANE DEFYNE WAS INCORRECTLY ADMINISTERED WITH 23 G CANNULA. THE CASE MEETS THE SERIOUSNESS CRITERIA FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES. EVALUATION TEXT: ROUTINE INVESTIGATIONS HAVE BEEN PERFORMED AND PROVIDE SUFFICIENT INFORMATION TO ASSESS THE POTENTIAL ROOT CAUSE AND INDICATE A POSSIBLE ASSOCIATION TO THE TREATMENT PROCEDURE. THE REPORTED LOT NUMBER WAS VALID AND VERIFIED THE REPORTED PRODUCT. A BATCH RECORD REVIEW WAS PERFORMED. NO POTENTIAL QUALITY ISSUES HAVE BEEN IDENTIFIED IN THE MANUFACTURING PROCESS OF THE SPECIFIED BATCH. THE BATCH IS MANUFACTURED AND RELEASED ACCORDING TO GALDERMA QUALITY MANAGEMENT SYSTEM. THE INFORMATION IN THIS CASE DOES NOT INDICATE A NON-CONFORMING PRODUCT OR MALFUNCTION. THE PERFORMED INVESTIGATIONS ARE THEREFORE CONSIDERED ADEQUATE AND NO ADDITIONAL INVESTIGATIONS WILL BE CONDUCTED. CAPA COMMENT: NO CORRECTIVE OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY BASED ON THE OUTCOME OF THE PERFORMED INVESTIGATIONS.

    Additional Manufacturer Narrative · 0

    COMPANY COMMENT: THE SERIOUS EVENTS OF SWELLING, MASS AT IMPLANT SITE AND THE NON-SERIOUS EVENTS OF INDURATION, BRUISING AT IMPLANT SITE AND DISCOMFORT AT INJECTION SITE WERE CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENT. SERIOUSNESS CRITERIA INCLUDE THE NEED FOR MULTIPLE MEDICAL INTERVENTIONS TO PREVENT PERMANENT DAMAGE. THE POTENTIAL ROOT CAUSE IS THE TREATMENT PROCEDURE. POTENTIAL CONTRIBUTORY FACTOR INCLUDES INJECTION TECHNIQUE AND PREVIOUS COSMETIC PROCEDURE OF ULTHERAPY. INTENTIONAL DEVICE MISUSE WAS REPORTED AS THE PRODUCT WAS INCORRECTLY ADMINISTERED WITH 23 G CANNULA. THE CASE MEETS THE SERIOUSNESS CRITERIA FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES. EVALUATION TEXT: ROUTINE INVESTIGATIONS HAVE BEEN PERFORMED AND PROVIDE SUFFICIENT INFORMATION TO ASSESS THE POTENTIAL ROOT CAUSE AND INDICATE A POSSIBLE ASSOCIATION TO THE TREATMENT PROCEDURE. THE REPORTED LOT NUMBER WAS VALID AND VERIFIED THE REPORTED PRODUCT. TO EXCLUDE A NON-CONFIRMING PRODUCT, A BATCH RECORD REVIEW WILL BE PERFORMED. CAPA COMMENT: NO CORRECTIVE OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY BASED ON THE OUTCOME OF THE PERFORMED INVESTIGATIONS.

    Description of Event or Problem · 0

    CASE REFERENCE NUMBER (B)(4) IS A SPONTANEOUS REPORT SENT ON 24-MAY-2023 BY A NURSE WHICH REFERS TO A 57-YEAR-OLD FEMALE PATIENT. THE MEDICAL HISTORY OF PATIENT INCLUDED RHEUMATOID ARTHRITIS AND AS PART OF THE CONDITION SHE HAS A REDUCED IMMUNE SYSTEM. CONCOMITANT MEDICATIONS INCLUDED NORDIMET [METHOTREXATE] 12.5 MG AND ERELZI [ETANERCEPT] 50 MG EVERY 3 WEEKS. ACCORDING TO REPORTER, THESE DOSES WERE INTENDED TO BE TAKEN EVERY WEEK, BUT THE PATIENT TAKES THEM EVERY 3 WEEKS. THE PATIENT HAD PREVIOUSLY RECEIVED TREATMENT WITH ULTHERAPY ON THE (B)(6) 2023 TO MARIONETTE LINES/JOWLS AREA. THE PATIENT BRIEFLY MENTIONED THAT SHE STILL FELT SORE AFTER ULTHERAPY. THE PATIENT ALSO SELF-MEDICATES WITH SEVERAL DIETARY SUPPLEMENTS AS BELOW: APPLE CIDER VINEGAR [APPLE CIDER VINEGAR] 1 TABLESPOON PER DAY, SHILAJIT A PEA SIZE PER DAY, MAGNESIUM [MAGNESIUM] 400 MG, VITAMIN D+K1/K2 2000 UNITS PER DAY, MCT OIL [MEDIUM-CHAIN TRIGLYCERIDES] 2 TABLESPOONS PER DAY, GLUCOSAMINE [GLUCOSAMINE] 1200 MG PER DAY, NAC [ACETYLCYSTEINE] 1000 MG 2 PER DAY, MACA [LEPIDIUM MEYENII] 5000 MG PER DAY, SELENIUM + ZINC + VITAMIN E + VITAMIN A (100UNITS/8MG/15UNITS/ 800 UNITS) PER DAY, FOLIC ACID [FOLIC ACID] 400 MG PER DAY, B5 120 MG PER DAY, CORE TRIBULUS + B6 1000MG/1.4MG PER DAY, LIONSMAINE AND CHAGA POWDER 1/2 TEASPOON OF EACH PER DAY, COQ10 [UBIDECARENONE] 100MG 1 PER DAY, CAYENNE PEPPER 1 TEASPOON, OLIVE OIL 2 TABLESPOONS, LEMON 1/2 SHOT EVERY DAY AND ASHWAGANDHA [WITHANIA SOMNIFERA] 605 MG PER DAY. SHE ALSO TAKES FISH OIL [FISH OIL] DAILY BUT HAS NOT TAKEN SINCE (B)(6) 2023 DUE TO THE AESTHETIC TREATMENT AT THE CLINIC. ON (B)(6) 2023, THE PATIENT RECEIVED TREATMENT WITH 2 ML OF RESTYLANE DEFYNE (LOT 21313), 1 ML TO EACH SIDE OF THE FACE IN THE MARIONETTE LINES, JOWLS AREA, CHIN AND ACCORDION LINES (I.E., VERTICAL LINES) ON CHEEKS USING 23 G CANNULA WITH FANNING TECHNIQUE BY ANOTHER NURSE. THE RESTYLANE DEFYNE WAS INJECTED USING 23 G CANNULA (INTENTIONAL DEVICE MISUSE). SAME DAY, THE PATIENT ALSO RECEIVED TREATMENT WITH 0.3 ML OF RESTYLANE REFYNE (LOT 20432-1) TO NASOLABIAL AREA AND 0.2 ML OF RESTYLANE NOS (UNKNOWN LOT NUMBER) AROUND MOUTH, DISTRIBUTED ABOVE AND BELOW THE MOUTH WITH UNKNOWN INJECTION TECHNIQUE AND NEEDLE TYPE. THREE DAYS AFTER THE TREATMENT, ON (B)(6) 2023, THE PATIENT RETURNED TO THE CLINIC AS THE TREATMENT AREA HAD SWELLED (IMPLANT SITE SWELLING) TO DOUBLE SIZE AND BECAME HARD/STIFF (IMPLANT SITE INDURATION). ACCORDING TO THE REPORTING NURSE, SHE SUSPECTED THAT RESTYLANE HAD BEEN INJECTED TOO DEEPLY, SINCE THERE WAS ALSO BRUISING (IMPLANT SITE BRUISING) ON THE BACKSIDE/ INSIDE OF THE SKIN. THE REPORTING NURSE HAD TRIED TO DISSOLVE THE AREA WITH HYALURONIDASE [HYALURONIDASE] BUT IT WAS VERY DIFFICULT TO EMPTY THE SYRINGES WITH HYALURONIDASE INTO THE TREATED AREA. THE HCP HAD TO USE THREE TIMES AS MUCH HYALURONIDASE AS EXPECTED/ACCORDING TO NORMAL PROCEDURE. ON (B)(6) 2023, THE PATIENT WAS A BIT UPSET ABOUT THE TREATMENT AROUND THE MOUTH BECAUSE SHE FELT VERY HEAVY. THERE WAS THICKENING OF THE PRODUCT WHICH COULD BE SEEN AND FELT, WHICH ALSO BOTHERED HER. THE HCP CONSIDERED THAT THIS SHOULD BE DISSOLVED. ON (B)(6) 2023, THE PATIENT VISITED HCP SINCE THE SWELLING HAD INCREASED FURTHER FROM THE CORNERS OF THE MOUTH DOWN TO THE HAMSTER POUCH ON THE CHEEK ON THE LEFT SIDE, AS WELL AS A BEGINNING OF SWELLING ON THE RIGHT SIDE. THE REPORTING NURSE HAS STATED THAT THE PATIENT HAD EXPLAINED THAT IT FELT LIKE A PRESSURE (INJECTION SITE DISCOMFORT), LIKE THERE WAS LACKING SPACE FOR THE PRODUCT. THEY HAD A CONSULTATION WITH THE DERMATOLOGIST, AND IT WAS DECIDED TO START TREATMENT WITH UNSPECIFIED ANTIBIOTICS. THE FILLER WAS DISSOLVED WITH 1 ML OF HYALURONIDASE [HYALURONIDASE] ON THE LEFT SIDE AND WITH 0.5 ML ON THE RIGHT SIDE, USING A SHARP NEEDLE. ON (B)(6) 2023, THE DERMATOLOGIST ASSESSED THE AREA. THERE WAS A SLIGHTLY FIRM SWELLING ON THE LEFT SIDE OF THE JAW TOWARDS THE CHIN BUT NO REDNESS OR FEELING OF HEAT. NO TENDERNESS WHEN PALPATED. ACCORDING TO THE NURSE, THERE WAS VISIBLE IMPROVEMENT. IT WAS DISSOLVED AGAIN WITH 1.5 ML ON THE LEFT SIDE, AND 0.5 ML ON THE RIGHT SIDE WITH HYALURONIDASE. THE PATIENT APPLIED A COOLING PAD, AND SHE WAS INFORMED TO CONTACT HCP IN CASE OF DETERIORATION. ON (B)(6) 2023, THE PATIENT WAS SEEN AGAIN, AND LITTLE IMPROVEMENT WAS SEEN AFTER THE LAST HYALURONIDASE TREATMENT. IT WAS DISSOLVED AGAIN TODAY WITH HYALURONIDASE 1.4 ML ON THE LEFT SIDE, AND 0.6 ML ON THE RIGHT SIDE. A COOLING PAD WAS APPLIED TO THE AREA, AND SHE WAS INFORMED TO CONTACT HCP IN CASE OF DETERIORATION. ON (B)(6) 2023, THE PATIENT WAS SEEN BY HCP AGAIN, AND LARGE IMPROVEMENT WAS SEEN AFTER THE LAST HYALURONIDASE TREATMENT. IT WAS DISSOLVED AGAIN WITH 1.5 ML ON THE LEFT SIDE, AND 0.5 ML ON THE RIGHT USING HYALURONIDASE. A COOLING PAD WAS APPLIED SINCE THERE WAS A SMALL HEMATOMA (IMPLANT SITE HAEMATOMA). ON (B)(6) 2023, THE HCP REPORTED THAT SIGNIFICANT IMPROVEMENT COULD BE SEEN AFTER THE HYALURONIDASE TREATMENT. THE PATIENT EXPERIENCED THE SAME. IT WAS DISSOLVED AGAIN WITH 1.6 ML ON THE LEFT SIDE, AND 0.4 ML OF RIGHT HYALURONIDASE. ON (B)(6) 2023, THE HCP REPORTED THAT ALL THE PRODUCT WAS ALMOST GONE AFTER THE LAST HYALURONIDASE TREATMENT. THE PATIENT EXPERIENCED THE SAME. IT WAS DISSOLVED AGAIN WITH 1.6 ML ON THE LEFT SIDE, AND 0.4 ML ON THE RIGHT. THE PATIENT WAS INFORMED TO CONTACT IN CASE OF DETERIORATION. THE PATIENT HAS NEXT SCHEDULED VISIT ON (B)(6) 2023. THE NURSE HAS FURTHER STATED THAT THERE WAS NO INSTANT EFFECT SEEN AFTER ANY OF THE TREATMENT OCCASIONS WITH HYALURONIDASE, BUT THERE HAS BEEN SMALL IMPROVEMENT OVER TIME FROM TREATMENT TO TREATMENT. AFTER THE LAST HYALURONIDASE TREATMENT ON (B)(6) 2023, THE SWELLING WAS STILL NOT COMPLETELY GONE AND THERE WERE SOME SMALL HARD LUMPS (IMPLANT SITE MASS) LEFT. HOWEVER, A BIG IMPROVEMENT HAS BEEN SEEN AND THE NURSE HAS ASSESSED THAT THE SWELLING HAS REDUCED WITH 70 PERCENT. ON 08-JUN-2023, A FOLLOW-UP CONVERSATION WAS HELD AND IT WAS CONFIRMED THAT THE PATIENT WAS FULLY RECOVERED AFTER THE TREATMENTS, AND SHE HAD NO SYMPTOMS OR SIDE EFFECTS LEFT TO DATE. NO FURTHER HYALURONIDASE TREATMENTS HAVE BEEN PERFORMED SINCE THE (B)(6) 2023 OUTCOME AT THE TIME OF THE REPORT: SWELLED WAS RECOVERED/RESOLVED. LUMPS WAS RECOVERED/RESOLVED. HARD/STIFF WAS RECOVERED/RESOLVED. BRUISING WAS RECOVERED/RESOLVED. FELT LIKE A PRESSURE WAS RECOVERED/RESOLVED. HEMATOMA WAS RECOVERED/RESOLVED. USING 23 G CANNULA WAS RECOVERED/RESOLVED. TRACKING LIST: V.0 INITIAL V.1 FU RECEIVED ON 09-JUN-2023 FROM THE SAME REPORTER AND ON 04-JUL-2023 FROM SAME REPORTER VIA OFFICE STAFF (RECEPTIONIST). EVENT (HEMATOMA) AND SUSPECT DEVICE RESTYLANE REFYNE AND RESTYLANE NOS WERE ADDED. PATIENT INITIALS, MEDICAL HISTORY, CONCOMITANT MEDICATION/DIETARY SUPPLEMENTS, RESTYLANE DEFYNE DEVICE LOCATION, OUTCOME OF EVENTS AND CORRECTIVE TREATMENT DETAILS WERE UPDATED.

    Description of Event or Problem · 0

    CASE REFERENCE NUMBER (B)(4) IS A SPONTANEOUS REPORT SENT ON (B)(6) 2023 BY A NURSE WHICH REFERS TO A 57-YEAR-OLD FEMALE PATIENT. THE MEDICAL HISTORY OF PATIENT INCLUDED RHEUMATOID ARTHRITIS AND AS PART OF THE CONDITION SHE HAS A REDUCED IMMUNE SYSTEM. CONCOMITANT MEDICATIONS INCLUDED METROXAT PRESUMED TO BE METHOTREXATE [METHOTREXATE] AND EXTRETE. THE PATIENT ALSO SELF-MEDICATES WITH SEVERAL UNSPECIFIED FOOD SUPPLEMENTS. THE PATIENT HAD PREVIOUSLY RECEIVED TREATMENT WITH ULTHERAPY ON THE (B)(6) 2023 TO MARIONETTE LINES/JOWLS AREA. ON (B)(6) 2023, THE PATIENT RECEIVED TREATMENT WITH 2 ML OF RESTYLANE DEFYNE (LOT 21313), 1 ML TO EACH SIDE OF THE FACE IN THE MARIONETTE LINES/JOWLS AREA USING 23 G CANNULA WITH FANNING TECHNIQUE BY ANOTHER NURSE. USING 23 G CANNULA (INTENTIONAL DEVICE MISUSE). THREE DAYS AFTER THE TREATMENT, ON (B)(6) 2023, THE PATIENT RETURNED TO THE CLINIC AS THE TREATMENT AREA HAD SWELLED (IMPLANT SITE SWELLING) TO DOUBLE SIZE AND BECAME HARD/STIFF (IMPLANT SITE INDURATION). ACCORDING TO THE REPORTING NURSE, SHE SUSPECTED THAT RESTYLANE HAD BEEN INJECTED TOO DEEPLY, SINCE THERE WAS ALSO BRUISING (IMPLANT SITE BRUISING) ON THE BACKSIDE/ INSIDE OF THE SKIN. THE REPORTING NURSE HAD TRIED TO DISSOLVE THE AREA WITH HYALURONIDASE [HYALURONIDASE] BUT IT WAS VERY DIFFICULT TO EMPTY THE SYRINGES WITH HYALURONIDASE INTO THE TREATED AREA. THE HCP HAD TO USE THREE TIMES AS MUCH HYALURONIDASE AS EXPECTED/ACCORDING TO NORMAL PROCEDURE. THE PATIENT RECEIVED THE FIRST HYALURONIDASE INJECTION 14 DAYS AFTER THE RESTYLANE TREATMENT ON (B)(6) 2023 AND THE REPORTING NURSE HAS STATED THAT THE PATIENT HAD EXPLAINED THAT IT FELT LIKE A PRESSURE (INJECTION SITE DISCOMFORT), LIKE THERE WAS LACKING SPACE FOR THE PRODUCT. THE PATIENT WAS STARTED ON UNSPECIFIED ANTIBIOTICS ON (B)(6) 2023. THE HYALURONIDASE TREATMENTS WERE GIVEN ACCORDING TO THE FOLLOWING SCHEME: (B)(6) 2023 - 1 ML LEFT SIDE + 0.5 ML RIGHT. (B)(6) 2023 - 1.5 ML LEFT SIDE + 0.5 ML RIGHT. (B)(6) 2023 - 1.4 ML LEFT SIDE + 0.6 ML RIGHT. (B)(6) 2023 - 1.5 ML LEFT SIDE + 0.5 ML RIGHT. (B)(6) 2023 - 1.6 ML LEFT SIDE + 0.4 ML RIGHT. (B)(6) 2023 - 1.6 ML LEFT SIDE + 0.4 ML RIGHT. THE NURSE HAS FURTHER STATED THAT THERE WAS NO INSTANT EFFECT SEEN AFTER ANY OF THE TREATMENT OCCASIONS WITH HYALURONIDASE, BUT THERE HAS BEEN SMALL IMPROVEMENT OVER TIME FROM TREATMENT TO TREATMENT. AFTER THE LAST HYALURONIDASE TREATMENT ON (B)(6) 2023, THE SWELLING WAS STILL NOT COMPLETELY GONE AND THERE WERE SOME SMALL HARD LUMPS (IMPLANT SITE MASS) LEFT. HOWEVER, A BIG IMPROVEMENT HAS BEEN SEEN AND THE NURSE HAS ASSESSED THAT THE SWELLING HAS REDUCED WITH 70 PERCENT. OUTCOME AT THE TIME OF THE REPORT: SWELLED WAS RECOVERING/RESOLVING. LUMPS WAS RECOVERING/RESOLVING. HARD/STIFF WAS RECOVERING/RESOLVING. BRUISING WAS UNKNOWN. FELT LIKE A PRESSURE WAS UNKNOWN. USING 23 G CANNULA WAS RECOVERED/RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778791 RESTYLANE DEFYNE IMPLANT, DERMAL, FOR AESTHETIC USE LMH Q-MED 21313

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention ACETYLCYSTEINE| APPLE CIDER VINEGAR| CAPSICUM SPP.| ETANERCEPT| EXTRETE| EXTRETE| FISH OIL| FOLIC ACID| GLUCOSAMINE| MACA [LEPIDIUM MEYENII]| MAGNESIUM| MEDIUM-CHAIN TRIGLYCERIDES| METHOTREXATE| METHOTREXATE| OLIVE OIL| UBIDECARENONE| ULTHERAPY TO MARIONETTE LINES/JOWLS AREA| ULTHERAPY TO MARIONETTE LINES/JOWLS AREA| WITHANIA SOMNIFERA