BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE REFYNE

    MDR report key: 6974198 · Received October 24, 2017

    Report

    Report Number
    9710154-2017-00084
    Event Type
    Injury
    Date Received
    October 24, 2017
    Report Date
    November 21, 2017
    Manufacturer
    GALDERMA- Q-MED
    Product Code
    LMH
    PMA / PMN Number
    P140029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTING EXEMPTION NUMBER E210500. REGISTRATION NUMBER: 9710154. (B)(4). EMERVEL CLASSIC LIDOCAINE IS THE INTERNATIONAL NAME FOR RESTYLANE REFYNE. CAPA: THE EVENTS OF EYE SWELLING, LIP SWELLING AND PRURITUS ARE EXPECTED. THE EVENT OF PHARYNGEAL OEDEMA IS UNEXPECTED AND POSSIBLY RELATED TO THE TREATMENT. NO CORRECTIVE OR PREVENTIVE ACTION IS NEEDED. MANUFACTURER NARRATIVE: LOT NUMBER WAS NOT REPORTED. PHARMACOVIGILANCE COMMENT: THE SERIOUS, UNEXPECTED EVENT OF PHARYNGEAL OEDEMA WAS CONSIDERED POSSIBLY RELATED TO THE TREATMENT. THE SERIOUS CRITERIA INCLUDED THE POTENTIAL RISK THAT THE EVENT MIGHT LEAD TO DISABILITY OR PERMANENT DAMAGE. THE NON-SERIOUS EVENTS OF LIP SWELLING, EYE SWELLING AND PRURITUS WERE CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENT. A POSSIBLE ETIOLOGY FOR THE EVENTS INCLUDES HYPERSENSITIVITY WITH ANGIOEDEMA. ALTERNATIVE ETIOLOGIES OR CONTRIBUTORY FACTORS MIGHT ALSO INCLUDE ALLERGY TO ENVIRONMENTAL OR FOOD TRIGGERS. THE CASE MEETS THE CRITERIA OF SERIOUSNESS AND CAUSALITY FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES. FOLLOW UP INFORMATION WILL BE REQUESTED. ADDITIONAL COMMENTS: DEVICE WAS NOT AVAILABLE TO MANUFACTURER VERSION 1. THREE FOLLOW-UP ATTEMPTS HAVE BEEN PERFORMED IN ORDER TO GATHER ADDITIONAL INFORMATION ABOUT THIS CASE. UNFORTUNATELY, NO RESPONSE WAS RECEVIED. NEW VERSION OF THE CASE WAS OPENED IN ORDER TO SUBMIT A FINAL REPORT TO THE REGULATORY AUTHORITIES.

    Additional Manufacturer Narrative · 1

    REPORTING EXEMPTION NUMBER (B)(4). REGISTRATION NUMBER:(B)(4). (B)(4) (IMPORTER) IS SUBMITTING ON BEHALF OF Q-MED AB (MANUFACTURER). ARISG CASE NUMBER: (B)(4). IMPORTER'S REPORT NUMBER: (B)(4). EMERVEL CLASSIC LIDOCAINE IS THE INTERNATIONAL NAME FOR RESTYLANE REFYNE. MEDRA CODES: (B)(4). CAPA: THE EVENTS OF EYE SWELLING, LIP SWELLING AND PRURITUS ARE EXPECTED. THE EVENT OF PHARYNGEAL OEDEMA IS UNEXPECTED AND POSSIBLY RELATED TO THE TREATMENT. NO CORRECTIVE OR PREVENTIVE ACTION IS NEEDED. LOT NUMBER WAS NOT REPORTED. PHARMACOVIGILANCE COMMENT: THE SERIOUS, UNEXPECTED EVENT OF PHARYNGEAL OEDEMA WAS CONSIDERED POSSIBLY RELATED TO THE TREATMENT. THE SERIOUS CRITERIA INCLUDED THE POTENTIAL RISK THAT THE EVENT MIGHT LEAD TO DISABILITY OR PERMANENT DAMAGE. THE NON-SERIOUS EVENTS OF LIP SWELLING, EYE SWELLING AND PRURITUS WERE CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENT. A POSSIBLE ETIOLOGY FOR THE EVENTS INCLUDES HYPERSENSITIVITY WITH ANGIOEDEMA. ALTERNATIVE ETIOLOGIES OR CONTRIBUTORY FACTORS MIGHT ALSO INCLUDE ALLERGY TO ENVIRONMENTAL OR FOOD TRIGGERS. THE CASE MEETS THE CRITERIA OF SERIOUSNESS AND CAUSALITY FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES. FOLLOW UP INFORMATION WILL BE REQUESTED. ADDITIONAL COMMENTS: THE SERIOUS CRITERIA INCLUDED THE POTENTIAL RISK THAT THE EVENT MIGHT LEAD TO DISABILITY OR PERMANENT DAMAGE.

    Description of Event or Problem · 1

    CASE REFERENCE NUMBER (B)(4) IS A SPONTANEOUS REPORT SENT ON (B)(6) 2017 BY AN NURSE WHICH REFERS TO A PATIENT AGED (B)(6) YEARS (GENDER UNKNOWN). NO INFORMATION WAS PROVIDED ABOUT MEDICAL HISTORY, CONCURRENT DISEASES, CONCOMITANT MEDICATION, HISTORY OF ALLERGIES OR PREVIOUS FILLER TREATMENTS. ON AN UNKNOWN DATE, THE PATIENT RECEIVED TREATMENT WITH EMERVEL CLASSIC LIDOCAINE TO THE ORAL COMMISSURES (LOT NUMBER, VOLUME, NEEDLE AND INJECTION TECHNIQUE WERE UNKNOWN). ON AN UNKNOWN DATE FOLLOWING THE INJECTION, THE PATIENT EXPERIENCED SWELLING IN THE THROAT(PHARYNGEAL OEDEMA), SWELLING IN THE EYE(EYE SWELLING) AND SWELLING IN THE LIP(LIP SWELLING). THE PATIENT ALSO EXPERIENCED ITCHY SKIN(PRURITUS) AT UNKNOWN AREA. AT THE TIME OF THE REPORT, THE OUTCOME FOR THE REPORTED EVENTS WAS UNKNOWN. TRACKING LIST: VERSION 1. THREE FOLLOW-UP ATTEMPTS HAVE BEEN PERFORMED IN ORDER TO GATHER ADDITIONAL INFORMATION ABOUT THIS CASE. UNFORTUNATELY, NO RESPONSE WAS RECEIVED. NEW VERSION OF THE CASE WAS OPENED IN ORDER TO SUBMIT A FINAL REPORT 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 AN NURSE WHICH REFERS TO A PATIENT AGED (B)(6) (GENDER UNKNOWN). NO INFORMATION WAS PROVIDED ABOUT MEDICAL HISTORY, CONCURRENT DISEASES, CONCOMITANT MEDICATION, HISTORY OF ALLERGIES OR PREVIOUS FILLER TREATMENTS. ON AN UNKNOWN DATE, THE PATIENT RECEIVED TREATMENT WITH EMERVEL CLASSIC LIDOCAINE TO THE ORAL COMMISSURES (LOT NUMBER, VOLUME, NEEDLE AND INJECTION TECHNIQUE WERE UNKNOWN). ON AN UNKNOWN DATE FOLLOWING THE INJECTION, THE PATIENT EXPERIENCED SWELLING IN THE THROAT(PHARYNGEAL OEDEMA), SWELLING IN THE EYE(EYE SWELLING) AND SWELLING IN THE LIP(LIP SWELLING). THE PATIENT ALSO EXPERIENCED ITCHY SKIN(PRURITUS) AT UNKNOWN AREA. AT THE TIME OF THE REPORT, THE OUTCOME FOR THE REPORTED EVENTS WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751070 RESTYLANE REFYNE IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA- Q-MED

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Disability