BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE PERLANE LIDOCAINE

    MDR report key: 6993258 · Received November 1, 2017

    Report

    Report Number
    9710154-2017-00088
    Event Type
    Injury
    Date Received
    November 1, 2017
    Report Date
    November 1, 2017
    Manufacturer
    GALDERMA Q-MED
    Product Code
    LMH
    PMA / PMN Number
    P040024/S039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    GALDERMA LABORATORIES L.P. (IMPORTER) IS SUBMITTING ON BEHALF OF Q-MED AB (MANUFACTURER) EXEMPTION NUMBER: E2015005 GALDERMA LABORATORIES L.P., IMPORTER REGISTRATION NO. 1000118068 Q-MED AB, MANUFACTURER, REGISTRATION NO. 9710154 IT17003270 ( VERSION 2) INITIAL REPORT CAPA: THE EVENTS ARE EXPECTED. NO REMEDIAL ACTION/CORRECTIVE ACTION/PREVENTIVE ACTION/FIELD SAFETY CORRECTIVE ACTION WILL BE INITIATED. MANUFACTURING NARRATIVE: THERE ARE NO INCREASED TRENDS OF MEDICAL COMPLAINTS FOR THE REPORTED LOT NUMBER 14114. NO POTENTIAL QUALITY ISSUES HAVE BEEN IDENTIFIED IN THE MANUFACTURING PROCESS OF THE SPECIFIED BATCH, 14114. THE BATCH IS MANUFACTURED AND RELEASED ACCORDING TO GALDERMA UPPSALA QUALITY MANAGEMENT SYSTEM. PHARMACOVIGILANCE COMMENTS:THE SERIOUS EVENT OF OEDEMA AT THE IMPLANT SITE WAS CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENT. SERIOUS CRITERIA INCLUDE THE NEED FOR SURGICAL INTERVENTION TO TREAT THE ADVERSE EVENTS. THE NON-SERIOUS EVENTS OF INDURATION AND PAIN AT THE IMPLANT SITE WERE CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENT. THIS CASE MEETS THE CRITERIA OF SERIOUSNESS AND CAUSALITY FOR EXPEDITED REPORTING TO REGULATORY AUTHORITIES. THE CASE WAS UPGRADED TO SERIOUS DUE TO THE FOLLOW-UP INFORMATION RECEIVED ON 04-OCT-2017. ADDITIONAL COMMENTS: H10 IT WAS NOT KNOWN IF THE DEVICE WAS AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 0

    CASE REFERENCE NUMBER (B)(4) IS A SPONTANEOUS REPORT SENT ON (B)(6) 2017 BY A PHYSICIAN. THIS NARRATIVE IS ALSO BASED ON FOLLOW-UP INFORMATION RECEIVED ON 16-MAY-2016 FROM THE PHYSICIAN. THE REPORT REFERS TO A FEMALE PATIENT (B)(6) YEARS. THE PATIENT HAD PREVIOUSLY RECEIVED TREATMENT WITH RESTYLANE SKINBOOSTER VITAL ON THE FACE AROUND (B)(6) 2016 (WITH MONTHLY FREQUENCY), AND BOTULINUM TOXIN IN (B)(6) 2016 AT THE SUPERIOR AREA OF THE GLABELLAR REGION. ON (B)(6) 2016, THE PATIENT RECEIVED TREATMENT WITH 1 ML (0.5 ML LEFT + 0.5 ML RIGHT) RESTYLANE PERLANE LIDOCAINE (LOT 14114) TO THE JAW LINE AND MARIONETTE LINES USING A BOLUS NEEDLE AND UNKNOWN INJECTION TECHNIQUE. IN (B)(6) 2017, THE PATIENT EXPERIENCED SEVERE INDURATION (IMPLANT SITE INDURATION) AND OEDEMA/SWELLING WALNUT-SIZE LIKE/PAINLESS SWELLING(IMPLANT SITE OEDEMA) AT THE JAW LINE ON BOTH SIDES OF THE FACE. INFLAMMATORY REACTIONS WERE NOT REPORTED. SPORADIC SWELLING WAS REPORTED BY THE PHYSICIAN (HOWEVER, UNCLEAR IF IT REFERRED TO THIS PATIENT OR NOT). TREATMENTS FOR THE ADVERSE EVENT INCLUDED (WITHOUT REPORTS OF SPECIFIC DATES): A SHORT CYCLE OF STEROID THERAPY [STEROIDS], WHICH DID NOT HAVE ANY EFFECT ON THE EVENT. AMOXICILLIN + CALVULANIC ACID [CLAVULANATE POTASSIUM][AMOXICILLIN TRIHYDRATE]: 875 + 125 MG TWICE DAILY FOR 15 DAYS. PREDNISONE [PREDNISONE]: 25 MG TWICE DAILY FOR 5 DAYS, THEN THE DOSE WAS GRADUALLY REDUCED FOR A TOTAL OF 15 DAYS OF TREATMENT. BROMELAIN TABLETS [BROMELAINS]: TWICE DAILY (TREATMENT WAS ONGOING AT THE TIME OF THE FOLLOW-UP REPORT ON 16-MAY-2017). SERRATIOPEPTIDASE TABLETS [SERRAPEPTASE]: TWICE DAILY (TREATMENT WAS ONGOING AT THE TIME OF THE FOLLOW-UP REPORT ON 16-MAY-2017). AT THE TIME OF THE FOLLOW-UP REPORT ON 16-MAY-2017, THE OUTCOME OF THE ADVERSE EVENTS WAS CONSIDERED AS RESOLVING. HOWEVER, THERE WERE AREAS IN WHICH MINOR PAINLESS SWELLING WAS PRESENT AND ALSO A SMALL INDURATION, REPORTED AS PROBABLY REFERRED TO THE INJECTED SUBSTANCE. ON (B)(6) 2017, FOLLOW-UP INFORMATION WAS RECEIVED FROM THE PHYSICIAN. IT WAS REPORTED THAT 11 MONTHS AFTER THE TREATMENT WITH RESTYLANE PERLANE LIDOCAINE THE EVENTS HAD NOT YET RESOLVED. IT WAS SPECIFIED THAT THERE WERE STILL MANY AREAS THAT WERE MILD PAINFUL(IMPLANT SITE PAIN) AND SUDDENLY APPEARED SWOLLEN. ONE OF THESE AREAS WAS INCISED BY THE PHYSICIAN WITH A NEEDLE (16MM) LEADING TO HYALURONIC ACID EXTRUSION THAT APPEARED INTACT AS (IF) IT HAD BEEN INJECTED THE DAY BEFORE. OUTCOME AT THE TIME OF THE REPORT: INDURATION WAS RECOVERING/RESOLVING. OEDEMA/SWELLING WALNUT-SIZE LIKE/PAINLESS SWELLING WAS NOT RECOVERED/NOT RESOLVED. MILD PAINFUL WAS NOT RECOVERED/NOT RESOLVED. TRACKING LIST: VERSION 0. INITIAL. VERSION 1. FU RECEIVED ON 16-MAY-2017: TREATMENT AREA (MARIONETTE LINES), OUTCOME OF EVENTS, TREATMENTS FOR ADVERSE EVENTS AND MORE DETAILS ON TREATED AREA FOR BOTOX WERE PROVIDED. VERSION 2. FU RECEIVED ON 04-OCT-2017: TREATMENT FOR THE ADVERSE EVENTS (INCISION), NEW EVENT (IMPLANT SITE PAIN) AND OUTCOME (NOT RECOVERED) WAS PROVIDED. THIS VERSION WAS UPGRADED TO SERIOUS ON (B)(6) 2017 DUE TO THE REQUIRED SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773589 RESTYLANE PERLANE LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA Q-MED 14114

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention