BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE LIDOCAINE

    MDR report key: 6839252 · Received September 1, 2017

    Report

    Report Number
    9710154-2017-00074
    Event Type
    Injury
    Date Received
    September 1, 2017
    Date of Event
    August 17, 2017
    Report Date
    September 19, 2017
    Manufacturer
    GALDERMA Q-MED
    Product Code
    LMH
    PMA / PMN Number
    P040024/S039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) IS SUBMITTING ON BEHALF OF Q-MED AB (MANUFACTURER) . EXEMPTION NUMBER: E2015005. (B)(4), IMPORTER REGISTRATION NO. (B)(4). Q-MED AB, MANUFACTURER, REGISTRATION NO. (B)(4). (B)(4) FOLLOW-UP REPORT 1 (DOWNGRADED). CAPA: THE EVENT OF VITREOUS FLOATERS IS UNEXPECTED AND UNRELATED TO THE TREATMENT. NO CORRECTIVE OR PREVENTIVE ACTION IS NEEDED. MANUFACTURING NARRATIVE: LOT NUMBER WAS NOT REPORTED. PHARMACOVIGILANCE COMMENTS: THE CASE WAS DOWNGRADED TO NON-SERIOUS ON 07-SEP-2017 BY THE MEDICAL EXPERT BASED ON THE FOLLOW-UP INFORMATION FROM THE REPORTING PHYSICIAN. THE PHYSICIAN DIAGNOSED THE PATIENT WITH FLOATERS. THE NON-SERIOUS EVENT OF VITREOUS FLOATERS WAS CONSIDERED UNEXPECTED AND UNRELATED TO THE TREATMENT. THE PATIENT DID NOT REQUIRE MEDICAL TREATMENT AND THERE WAS NO OBVIOUS IMPACT ON HER ACTIVITIES OF DAILY LIVING. ALTERNATIVE ETIOLOGIES INCLUDE MEDICAL HISTORY AND AGING. THE CASE DOES NOT MEET THE CRITERIA FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES.

    Additional Manufacturer Narrative · 1

    (B)(4). CAPA: THE EVENT OF VISUAL IMPAIRMENT IS EXPECTED. NO CORRECTIVE OR PREVENTIVE ACTION IS NEEDED. MANUFACTURING NARRATIVE: LOT NUMBER WAS NOT REPORTED. PHARMACOVIGILANCE COMMENTS: THE SERIOUS, EXPECTED EVENT OF VISUAL IMPAIRMENT WAS CONSIDERED POSSIBLY RELATED TO THE TREATMENT PROCEDURE. SERIOUS CRITERIA INCLUDE POTENTIAL DISABILITY. POTENTIAL CONTRIBUTORY FACTOR TO THE EVENT INCLUDE INJECTION TECHNIQUE. THIS CASE MEETS THE CRITERIA OF SERIOUSNESS AND CAUSALITY FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES. FURTHER INFORMATION HAS BEEN REQUESTED. ADDITIONAL COMMENTS:NO INFORMATION WAS MADE AVAILABLE FOR DEVICE EVALUATION BY THE MANUFACTURER.

    Description of Event or Problem · 1

    CASE REFERENCE NUMBER (B)(4) IS A SPONTANEOUS REPORT SENT ON 20-AUG-2017 AND A FOLLOW-UP REPORT ON 01-SEP-2017 BY A COMPANY REPRESENTATIVE WHICH REFERS TO A (B)(6)-YEARS OLD FEMALE PATIENT. NO INFORMATION WAS PROVIDED ABOUT THE PATIENT'S MEDICAL HISTORY, CONCURRENT DISEASES, CONCOMITANT MEDICATION, HISTORY OF ALLERGIES OR PREVIOUS FILLER TREATMENTS. ON (B)(6) 2017, THE PATIENT RECEIVED TREATMENT WITH 1ML RESTYLANE LIDOCAINE TO THE TEAR TROUGHS (LOT NUMBER, NEEDLE AND INJECTION TECHNIQUE UNKNOWN). FEW DAYS LATER, THE PATIENT FELT THE VISION HAS BEEN DAMAGED (VISUAL IMPAIRMENT). ON (B)(6) 2017, THE PATIENT VISITED A PHYSICIAN AT THE OPHTHALMIC CLINIC FOR HER VISION ISSUE AND WAS DIAGNOSED WITH FLOATERS(VITREOUS FLOATERS). THE PATIENT DID NOT GO BACK TO THE PREVIOUS CLINIC BECAUSE SHE WAS TOO BUSY. THEREFORE, THE PATIENT DID NOT RECEIVE ANY TREATMENT FOR THE ADVERSE EVENT. OUTCOME AT THE TIME OF THE REPORT: FLOATERS WAS UNKNOWN. TRACKING LIST: VERSION 0. INITIAL . VERSION 1. FU RECEIVED ON (B)(6) 2017: FILLED-IN FORM WAS RECEIVED FROM THE PHYSICIAN AND INCLUDED PATIENT INITIALS, AGE, UPDATED SUSPECT PRODUCT (RESTYLANE LIDOCAINE), DIAGNOSIS OF PATIENT'S CONDITION AND REPORTER SERIOUSNESS (NON-SERIOUS). THE CASE HAS BEEN DOWNGRADED TO NON-SERIOUS BASED ON THE FOLLOW-UP INFORMATION FROM THE REPORTING PHYSICIAN. THE PHYSICIAN DIAGNOSED THE PATIENT WITH FLOATERS AND THE PATIENT DID NOT REQUIRE MEDICAL TREATMENT. THE NON-SERIOUS EVENT OF VITREOUS FLOATERS WAS CONSIDERED UNEXPECTED AND UNRELATED TO THE TREATMENT. ALTERNATIVE ETIOLOGIE INCLUDES MEDICAL HISTORY AND AGING. THE CASE DOES NOT MEET THE CRITERIA FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES.

    Description of Event or Problem · 1

    CASE REFERENCE NUMBER (B)(4) IS A SPONTANEOUS REPORT SENT ON (B)(6) 2017 BY A COMPANY REPRESENTATIVE WHICH REFERS TO A FEMALE PATIENT (AGE UNKNOWN). NO INFORMATION WAS PROVIDED ABOUT THE PATIENT'S MEDICAL HISTORY, CONCURRENT DISEASES, CONCOMITANT MEDICATION, HISTORY OF ALLERGIES OR PREVIOUS FILLER TREATMENTS. ON (B)(6) 2017, THE PATIENT RECEIVED TREATMENT WITH 1ML RESTYLANE TO THE TEAR TROUGH (LOT NUMBER, NEEDLE AND INJECTION TECHNIQUE UNKNOWN). CONCOMITANT TREATMENTS INCLUDED 2ML JUVEDERM J PLUS IN THE TEMPLE AND 2ML XEOMIN [BOTULINUM NEUROTOXIN A] IN THE FOREHEAD. EIGHT DAYS LATER, THE PATIENT FELT THE VISION HAS BEEN DAMAGED(VISUAL IMPAIRMENT). THEREFORE, THE PHYSICIAN WAS STRONGLY RECOMMENDED TO PROVIDE HYALURONIDASE ON THE TREATMENT AREA (UNKNOWN IF THE HYALURONIDASE TREATMENT WAS PERFORMED). FURTHERMORE, IT WAS REPORTED THAT THE PATIENT SHOULD HAVE PERFORMED A PARTICULAR EXAMINATION OF THE VISION. THE CLINIC HAD FOLLOWED THIS CASE FOR THE PAST TWO DAYS AT INITIAL REPORTING. THE PATIENT DID NOT HAVE THE INTENTION TO REVISIT THE DOCTOR OR TOOK THE ADVICE TO HAVE FURTHER EXAMINATION OF HER VISION BECAUSE SHE WAS BUSY. OUTCOME AT THE TIME OF THE REPORT: FELT THE VISION HAS BEEN DAMAGED WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619520 RESTYLANE LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA Q-MED UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Disability