BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE LIDOCAINE

    MDR report key: 6926743 · Received October 7, 2017

    Report

    Report Number
    9710154-2017-00080
    Event Type
    Injury
    Date Received
    October 7, 2017
    Date of Event
    May 31, 2012
    Report Date
    October 6, 2017
    Manufacturer
    GALDERMA Q-MED
    Product Code
    LMH
    PMA / PMN Number
    P040024/S039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    NURSE

    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 NO17008097 INITIAL REPORT CAPA: NO REMEDIAL ACTION/CORRECTIVE ACTION/PREVENTIVE ACTION/FIELD SAFETY CORRECTIVE ACTION WILL BE INITIATED. THE EVENTS OF VENOUS OCCLUSION, IMPLANT SITE NECROSIS, CAPILLARY DISORDER AND IMPLANT SITE DISCOLOURATION ARE EXPECTED. IT IS STATED IN THE WARNING SECTION IN THE IFU FOR THE RESTYLANE RANGE OF PRODUCTS THAT THE PRODUCT SHOULD NOT BE INJECTED INTRAVASCULARLY. AS FOR OTHER INJECTABLE MEDICAL DEVICES INADVERTENT INJECTION INTO BLOOD VESSELS COULD POTENTIALLY LEAD TO VASCULAR OCCLUSION ISCHEMIA AND NECROSIS. MANUFACTURING NARRATIVE: LOT NUMBER WAS NOT PROVIDED. PHARMACOVIGILANCE COMMENTS: THE SERIOUS, EXPECTED EVENTS OF VENOUS OBSTRUCTION AND IMPLANT SITE NECROSIS, AND THE NON-SERIOUS EVENTS OF CAPILLARY DISORDER AND IMPLANT SITE DISCOLOURATION WERE CONSIDERED POSSIBLY RELATED TO THE TREATMENT. SERIOUS CRITERIA INCLUDED THE NEED FOR MEDICAL INTERVENTION IN ORDER TO PREVENT PERMANENT DAMAGE. THE REPORTING NURSE PROVIDED THE ALTERNATIVE ETIOLOGY OF POSSIBLE GENETIC PREDISPOSITION FOR THE REPORTED EVENTS OF VENOUS OBSTRUCTION AND NECROSIS. OTHER ALTERNATIVE ETIOLOGIES FOR THESE EVENTS INCLUDE PREVIOUS NOSE SURGERIES AND LASER TREATMENTS TO THE REGION. THIS CASE MEETS THE CRITERIA OF SERIOUSNESS AND CAUSALITY FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES. ADDITIONAL COMMENTS: NO INFORMATION WAS RECEIVED REGARDING DEVICE EVALUATION.

    Description of Event or Problem · 0

    CASE REFERENCE NUMBER (B)(4) IS A SPONTANEOUS REPORT SENT ON 11-SEP-2017 BY A COSMETIC NURSE VIA A SALES REPRESENTATIVE. THIS NARRATIVE ALSO CONTAINS FOLLOW-UP INFORMATION RECEIVED FROM THE REPORTING NURSE ON (B)(6) 2017. THE NURSE REFERS TO A FEMALE PATIENT AGED (B)(6). THE PATIENT WAS NOT PREGNANT. THE PATIENT HAD PREVIOUSLY UNDERWENT RHINOPLASTY SURGERY TWICE (THIS WAS BEFORE 2002, HOWEVER, DATE AND PLACE ARE UNKNOWN). THE PATIENT WAS NOT PLEASED AFTER THE SURGERIES AND WANTED CORRECTION WITH RESTYLANE. ON (B)(6) 2012, THE PATIENT RECEIVED TREATMENT WITH 0.7ML RESTYLANE LIDOCAINE TO THE NASAL BRIDGE AND THE TIP OF THE NOSE (LOT NUMBER, VOLUME, NEEDLE AND INJECTION TECHNIQUE WERE UNKNOWN). THE TREATMENT WAS NOT PERFORMED BY THE REPORTING NURSE, BUT SHE COULD READ IN THE PATIENT'S JOURNAL. THE REPORTER WAS UNSURE WHETHER A SHARP NEEDLE OR PIX`L CANNULA WAS USED. THE NURSE AND THE SALES REPRESENTATIVE REPORTED THAT SEVEN DAYS AFTER THE TREATMENT, ON (B)(6) 2012, THE PATIENT EXPERIENCED VENOUS STASIS WITH POSSIBLE ARTERIAL IMPACT(VENOUS OCCLUSION) AND NECROSIS-LIKE COMPLICATION(IMPLANT SITE NECROSIS) ON THE NOSE TIP. TREATMENT FOR THE ADVERSE EVENT INCLUDED HYALASE [HYALURONIDASE] ON (B)(6) 2012. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED BROKEN BLOOD VESSELS(CAPILLARY DISORDER) ON THE TIP OF THE NOSE IN 2012 AND HAS BEEN TREATED WITH ND YAG-LASER FOUR TIMES; (B)(6) 2016, (B)(6) 2017. THE REPORTING NURSE PERFORMED THREE OF THESE TREATMENTS. THE TREATMENT GAVE SOME EFFECT, HOWEVER, THE EVENT SEEM TO ALWAYS RETURN AFTER SOME TIME. THE REPORTING NURSE MET THE PATIENT FOR THE FIRST TIME IN 2016. THE PATIENT BELIEVED THAT SHE STILL HAD DISCOLORATION(IMPLANT SITE DISCOLOURATION) ON THE NOSE TIP FOLLOWING THE COMPLICATION IN 2012, AND THAT SHE STILL HAD NOT RECOVERED. THE REPORTING NURSE WAS UNSURE WHETHER THE BROKEN BLOOD VESSELS THE PATIENT NOW HAD WERE CAUSED BY THE COMPLICATION, NATURAL AGING OR IF THEY WERE GENETIC. OUTCOME AT THE TIME OF THE REPORT: VENOUS STASIS WITH POSSIBLE ARTERIAL IMPACT WAS RECOVERED/RESOLVED. NECROSIS-LIKE COMPLICATION WAS RECOVERED/RESOLVED. BROKEN BLOOD VESSELS WAS NOT RECOVERED/NOT RESOLVED. DISCOLORATION WAS NOT RECOVERED/NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705992 RESTYLANE LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA Q-MED UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention