BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE-L (LIDOCAINE)

    MDR report key: 6918170 · Received October 5, 2017

    Report

    Report Number
    9710154-2017-00079
    Event Type
    Injury
    Date Received
    October 5, 2017
    Report Date
    October 4, 2017
    Manufacturer
    GALDERMA Q-MED
    Product Code
    LMH
    PMA / PMN Number
    P040024/S039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 US17008428 INITIAL REPORT (VERSION 1) CAPA: THE EVENTS ARE EXPECTED. NO CORRECTIVE OR PREVENTIVE ACTION WILL BE INITIATED. MANUFACTURING NARRATIVE: LOT NUMBER WAS NOT REPORTED. PHARMACOVIGILANCE COMMENTS: THE SERIOUS EVENTS OF NECROSIS, REDNESS, PAIN AND BLANCHING AT THE IMPLANT SITE WERE CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENT. CONTRIBUTORY FACTORS INCLUDE THE INJECTION TECHNIQUE. THE EVENTS RESOLVED. THE CASE DID MEET THE CRITERIA FOR EXPEDITED REPORTING TO REGULATORY AUTHORITY ADDITIONAL COMMENTS: DEVICE NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 0

    CASE REFERENCE NUMBER (B)(4) IS A SPONTANEOUS REPORT SENT ON 20-SEP-2017 AND A FOLLOW-UP REPORT ON 25-SEP-2017 BY A PHYSICIAN WHICH REFERS TO A (B)(6) FEMALE PATIENT. MEDICAL HISTORY OF HYPERTENSION. CONCOMITANT TREATMENTS AND ALLERGIES WERE NOT REPORTED. THE PATIENT HAD PREVIOUS TOXINS IN THE PAST AT ANOTHER FACILITY. SHE HAD NO FILLER HISTORY. ON (B)(6) 2017, THE PATIENT RECEIVED TREATMENT WITH 1 ML (0.5 ML TO EACH SIDE) OF RESTYLANE-L (LOT UNKNOWN) TO THE TEAR TROUGHS WITH AN UNKNOWN NEEDLE TYPE AND UNKNOWN INJECTION TECHNIQUE. AT 1-2 DAYS LATER AFTER THE INJECTION, SOMETIME OVER THE WEEKEND, THE PATIENT NOTED REDNESS (IMPLANT SITE ERYTHEMA) AND PAIN (IMPLANT SITE PAIN) ON THE LEFT CHEEK AND LEFT GUM. THREE DAYS LATER, ON (B)(6) 2017, THE PATIENT WAS SEEN BY THE PROVIDER'S PARTNER AND NOTED BLANCHABLE (IMPLANT SITE ISCHEMIA) ERYTHEMA. FOUR DAYS LATER, ON (B)(6) 2017, THE PATIENT EXPERIENCED NECROTIC TISSUE(IMPLANT SITE NECROSIS) NEAR THE ANGULAR ARTERY AND INFRAORBITAL ARTERY. TREATMENT FOR THE ADVERSE EVENT INCLUDED: HYALURONIDASE, NITRO-BID [GLYCERYL TRINITRATE] AND WARM COMPRESSES. THE PATIENT WAS SEEN DAILY TO BRING BACK BLOOD FLOW. OUTCOME AT THE TIME OF THE REPORT: THE EVENTS WERE RECOVERED/RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697312 RESTYLANE-L (LIDOCAINE) IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA Q-MED UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention