BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE, RESTYLANE

    MDR report key: 3170441 · Received June 11, 2013

    Report

    Report Number
    2032896-2013-00170
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    November 16, 2009
    Report Date
    January 28, 2010
    Manufacturer
    Q-MED
    Product Code
    LMH
    PMA / PMN Number
    P020023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT AND CONCLUSION OF MFR'S INVESTIGATION: THE COMPANY'S CAUSALITY FOR THE CASE IS POSSIBLY RELATED TO THE INJECTION PROCEDURE AND IS UNLIKELY TO BE RELATED TO THE DEVICE. THE NECROSIS IS PROBABLY RELATED TO THE INJECTION PROCEDURE AND CAUSED BY PRESSURE OCCLUSION OF A BATCH OF THE NASAL ARTERY. DILIGENT WOUND CARE IS IMPORTANT. THE HEALING PROCESS CAN TAKE A LONG TIME BEFORE FINAL RESULTS. PHOTOS FROM (B)(6) 2010, SHOW SCAR TISSUE WITH PRESUMABLE FIBROSIS, GIVING MEDIAL DEVIATION ON LEFT ALA. REASONABLE TO ASSUME THAT THIS CONDITION OF MEDIAL DEVIATION OF ALA WILL BE LONG TERM OR EVEN PERMANENT. HOWEVER, AS IN ALL HEALING PROCESSES AFTER NECROSIS FINAL OUTCOME CAN BE ESTIMATED AFTER 6 MONTHS. IMPLANT SITE NECROSIS FOLLOWING FILLER TREATMENT IS KNOWN AND THIS INFO IS DESCRIBED IN THE INSTRUCTION FOR USE. THIS CASE IS MORE SEVERELY AFFECTED THAN PREVIOUS CASES REPORTED TO US AND THERE IS VISIBLE TISSUE LOSS DESPITE HEALING OF THE AFFECTED LEFT NASAL ALA. THE PT HAS HAD PREVIOUS RHINOPLASTY AND WE DO NOT HAVE ANY INFO ON WHETHER THERE WAS ANY IMPLANT INSERTED DURING THAT PROCEDURE. IT IS POSSIBLE THAT THE PREVIOUS RHINOPLASTY PROCEDURE COULD HAVE LED TO FIBROSIS IN THE NOSE AND THEREFORE, THE ISCHEMIC PROCESS HAS LED TO A DEFECT FOLLOWING HEALING. TREND ANALYSIS SHOWS THAT THIS IS THE FIRST CASE OF IMPLANT SITE NECROSIS ON BATCH 9898. CONSIDERATION WILL BE MADE TO INCLUDE THIS CLINICAL SCENARIO IN THE INSTRUCTIONS FOR USE. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED FROM DOCTOR, (B)(4), CONCERNED ABOUT A PT OF AN UNK AGE. INCIDENT DESCRIPTION: CASE REFERENCE NUMBER (B)(6) 2010, IS A SPONTANEOUS CASE REPORT SENT BY A PHYSICIAN WHICH REFERS TO A FEMALE AGED (B)(6). THE PT'S MEDICAL HISTORY INCLUDES RHINOPLASTY [RHINOPLASTY]. THE PT HAS NO HISTORY OF ALLERGIES. THE PT HAS PREVIOUSLY BEEN TREATED WITH RESTYLANE SUBQ IN THE NASOLABIAL FOLDS IN (B)(6) - 2008. THE PT WAS TREATED WITH RESTYLANE (BATCH 9898-2) IN THE LEFT AND RIGHT NASAL ALA; 0.15 ML IN EACH, ON (B)(6) 2009. THE PRODUCT WAS INJECTED IN THE SUBCUTANEOUS TISSUE. IMMEDIATE POST INJECTION STATUS WAS UNREMARKABLE. THE ADVERSE EVENT IS: SEVERE NECROSIS LT ALA, NOSE [IMPLANT SITE NECROSIS] WHICH BEGAN ON (B)(6) 2009, THE SAME DAY AS THE INJECTION. THE NEXT DAY, (B)(6) 2009, THE PT WAS COMPLAINING ABOUT SWELLING AND PAIN OF LEFT ALA AND SHE WAS TREATED WITH 1 CC HYALURONIDASE IN LEFT NASAL ALA. THE COLOR OF THE LEFT ALA WAS OK ON THE SECOND DAY. DESPITE VIGOROUS TREATMENT, THE MIDDLE THIRD OF LEFT ALA PROGRESSED TO TOTAL LAYER NECROSIS. THE REACTION WAS DEEMED SERIOUS BY THE REPORTER BECAUSE IT REQUIRED INTERVENTION. THE NECROSIS HAS BEEN TREATED BY A DOCTOR IN U.S. BUT THE PT HAS BEEN FOLLOWED REGULARLY BY THE TREATING/REPORTING PHYSICIAN IN (B)(6). THE PT IS LIVING IN (B)(6). THE OUTCOME FOR NECROSIS LT ALA, NOSE [IMPLANT SITE NECROSIS] IS RECOVERED / RESOLVED WITH SEQUELAE. PHOTOS FROM (B)(6) 2010, SHOW SCAR TISSUE WITH PRESUMABLE FIBROSIS, GIVING MEDIAL DEVIATION ON LEFT ALA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263750 RESTYLANE, RESTYLANE INJECTABLE DERMAL FILLER LMH Q-MED 10-70012 9898-2

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention