BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE SILK

    MDR report key: 6133385 · Received November 29, 2016

    Report

    Report Number
    9710154-2016-00056
    Event Type
    Injury
    Date Received
    November 29, 2016
    Date of Event
    October 3, 2016
    Report Date
    November 16, 2016
    Manufacturer
    GALDERMA Q-MED
    Product Code
    LMH
    PMA / PMN Number
    P040024/S072
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A TREND ANALYSIS SHOWS THAT THERE ARE NO INCREASED TRENDS OF MEDICAL COMPLAINT FOR THE REPORTED LOT NUMBERS 13754 (RESTYLANE SILK) OR 14243 (RESTYLANE LYFT WITH LIDOCAINE). BATCH RECORD REVIEW FOR THE REPORTED LOT NUMBERS DID NOT REVEAL ANY DEVIATIONS OR OTHER OBSERVATIONS THAT INDICATE ANY PRODUCT DEFICIENCIES. ALL CHEMICAL AND MICROBIOLOGICAL TEST RESULTS WERE WITHIN THE SPECIFICATION LIMITS. THE EVENTS URTICARIA, HYPERSENSITIVITY AND SWELLING ARE ALREADY COVERED BY THE LABELING. THE EVENT ANGUISH IS ASSESSED AS SECONDARY TO THE HYPERSENSITIVITY REACTION. NO CORRECTIVE/PREVENTIVE ACTION IS NEEDED. PHARMACOVIGILANCE COMMENTS: A CAUSAL RELATION BETWEEN THE EVENTS AND THE TREATMENT SEEMS POSSIBLE. THE CASE HAS BEEN ASSESSED TO FULFILL THE SERIOUSNESS CRITERIA FOR REPORTING TO COMPETENT AUTHORITY BASED ON FOLLOW-UP INFORMATION RECEIVED ON 16-NOV-2016. THE CASE HAS BEEN ASSESSED TO FULFILL THE SERIOUSNESS CRITERIA FOR REPORTING TO COMPETENT AUTHORITY (DUE TO THE HOSPITALIZATION).

    Description of Event or Problem · 1

    CASE NUMBER (B)(4). A REPORT WAS RECEIVED ON 01-OCT-2016 BY THE INJECTING PHYSICIAN ASSISTANT. THE PHYSICIAN ASSISTANT REPORTED THAT A (B)(6) FEMALE PATIENT WAS INJECTED WITH A TOTAL OF 2ML OF RESTYLANE LYFT INTO THE NASOLABIAL FOLDS, 1 ML ON EACH SIDE. THE PATIENT ALSO RECEIVED 1ML OF RESTYLANE SILK INJECTED INTO THE LIPS ON (B)(6) 2016. ON THE EVENING OF (B)(6) 2016, THE PATIENT EXPERIENCED AN ABRUPT ONSET OF FACIAL SWELLING. THE REPORTER STATED THAT THE PATIENT'S ENTIRE FACE WAS SEVERELY SWOLLEN. THE LIPS WERE ALSO SWOLLEN, BUT IT WAS NOT AS SEVERE AS THE REMAINDER OF THE FACE. THE REPORTER DENIED ANY REDNESS OR BRUISING. THE PATIENT HAS NOT RECEIVED ANY TREATMENTS YET AND WAS PLANNING TO GO TO THE EMERGENCY ROOM. A FOLLOW UP REPORT WAS RECEIVED ON 10-OCT-2016 FROM THE DIRECTOR OF OPERATIONS AT THE SAME FACILITY AS THE REPORTING PHYSICIAN ASSISTANT. THE REPORTER STATED THE PATIENT WAS SEEN IN THE EMERGENCY ROOM AND WAS TREATED WITH UNSPECIFIED STEROIDS AND ANTIBIOTICS. A FOLLOW UP REPORT WAS RECEIVED ON 16-NOV-2016 FROM THE PHYSICIAN ASSISTANT. MEDICAL HISTORY INCLUDED RECENT HISTORY OF DEPRESSION AND A SKIN TYPE OF FITZPATRICK SCALE III-IV AND NO KNOWN ALLERGIES. PAST PRODUCTS INCLUDED HYALURONIC ACID INJECTED 4 YEARS PRIOR TO THIS REPORT WITH NO REPORTED ADVERSE EVENTS. CONCOMITANT MEDICATIONS INCLUDED ZOLOFT (SERTRALINE HYDROCHLORIDE) STARTED IN (B)(6) 2016, APPROXIMATELY 2 WEEKS PRIOR TO THE INJECTIONS WITH RESTYLANE SILK AND RESTYLANE LYFT. THE PHYSICIAN ASSISTANT REPORTED THE PATIENT RECEIVED 0.5 ML OF RESTYLANE SILK TO EACH THE UPPER AND LOWER LIPS USING THE NEEDLE SUPPLIED IN THE PRODUCT PACKAGING AND RECEIVED 1 ML OF RESTYLANE LYFT TO THE EACH THE LEFT AND RIGHT NASOLABIAL FOLD, ALSO USING THE NEEDLE SUPPLIED IN THE PRODUCT PACKAGING. THE REPORTER STATED THE PATIENT EXPERIENCED ABRUPT ONSET SWELLING TO THE ENTIRE FACE AND EYES. THE REPORTER STATED THE PATIENT HAD A HIVE LIKE RASH ON THE NECK, BUT DENIED ANY RESPIRATORY COMPROMISE. THE PATIENT WAS SEEN 1 MONTH POST INJECTION AFTER HAVING 2 HOSPITAL ADMISSIONS. THE PATIENT WAS REPORTED TO BE IMPROVING PHYSICALLY, BUT WAS ALSO IN ANGUISH OVER THE MEDICATION USED TO SUPPRESS THE IMMUNE REACTION. THE PHYSICIAN ASSISTANT REPORTED THE PATIENT WAS TREATED WITH PREDNISONE 50MG AND PEPCID (FAMOTIDINE). THE PHYSICIAN ASSISTANT REPORTED THE SWELLING GRADUALLY RESIDED FROM USING THE STEROID AND ANTIHISTAMINE. THE PATIENT WAS SCHEDULED TO HAVE A FOLLOW UP APPOINTMENT WITH AN ALLERGIST. THE REPORTER PROVIDED THREE UNDATED PHOTOS OF THE PATIENT'S FACE. THE REPORTING PHYSICIAN ASSISTANT ASSESSED THE LIP SWELLING AS MILD, THE FACIAL SWELLING AS SEVERE, AND DID NOT PROVIDE A SEVERITY ASSESSMENT FOR THE HIVE LIKE RASH OR ANGUISH. THE REPORTER ALSO ASSESSED THE EVENTS AS SERIOUS DUE TO A LIFE THREATENING ILLNESS OR INJURY AND MEDICAL INTERVENTION NEEDED TO TREAT THE LIFE THREATENING ILLNESS OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783385 RESTYLANE SILK IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA Q-MED 13754

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R ANTIBIOTICS| HYALURONIC ACID| PEPCID| PREDNISONE| ZOLOFT