BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE LIDOCAINE

    MDR report key: 7018065 · Received November 10, 2017

    Report

    Report Number
    9710154-2017-00093
    Event Type
    Injury
    Date Received
    November 10, 2017
    Date of Event
    October 10, 2017
    Report Date
    December 8, 2017
    Manufacturer
    GALDERMA Q-MED
    Product Code
    LMH
    PMA / PMN Number
    P040024/S039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIOUS, EXPECTED EVENTS OF VASCULAR OCCLUSION, EMBOLISM, VISUAL ACUITY REDUCED, AND THE SERIOUS, UNEXPECTED EVENT OF PAPILLOEDEMA WERE CONSIDERED POSSIBLY RELATED TO THE TREATMENT PROCEDURE. THE NON-SERIOUS EVENT OF IMPLANT SITE ERYTHEMA AND PAIN WERE CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENT. SERIOUS CRITERIA INCLUDED THE NEED FOR SEVERAL MEDICAL INTERVENTIONS TO PREVENT PERMANENT DAMAGE. POTENTIAL ETIOLOGIES INCLUDES INJECTION TECHNIQUE. THIS CASE MEETS THE CRITERIA OF SERIOUSNESS AND CAUSALITY FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES. THE EVENTS OF VASCULAR OCCLUSION, EMBOLISM, VISUAL ACUITY REDUCED, IMPLANT SITE ERYTHEMA AND PAIN ARE EXPECTED. THE EVENT OF PAPILLOEDEMA IS UNEXPECTED AND POSSIBLY RELATED. THIS EVENT IS CONSISTENT WITH THE KNOWN RISK FOR VASCULAR OCCLUSION. EYE DISORDERS ARE CLOSELY MONITORED. IT IS STATED IN THE WARNING SECTION IN THE INSTRUCTIONS FOR USE FOR THE RESTYLANE RANGE OF PRODUCTS THAT THE PRODUCT SHOULD NOT BE INJECTED INTRAVASCULARLY. AS FOR OTHER INJECTABLE MEDICAL DEVICES INADVERTENT INJECTION INTO BLOOD VESSELS COULD POTENTIALLY LEAD TO VASCULAR OCCLUSION ISCHEMIA AND NECROSIS. NO FURTHER CORRECTIVE OR PREVENTIVE ACTION IS WARRANTED AT THIS TIME. GALDERMA LABORATORIES, L.P. IS SUBMITTING THIS REPORT ON BEHALF OF Q-MED AB. EXEMPTION NUMBER: E2015005

    Description of Event or Problem · 0

    (B)(4) IS A SPONTANEOUS REPORT SENT ON 16-OCT-2017 BY A PHYSICIAN VIA THE LSO WHICH REFERS TO A FEMALE PATIENT OF UNKNOWN AGE. THIS NARRATIVE IS ALSO BASED ON FOLLOW-UP INFORMATION RECEIVED ON 20-OCT-2017 AND 24-OCT-2017 FROM THE PHYSICIAN. NO INFORMATION WAS PROVIDED ABOUT THE PATIENT'S MEDICAL HISTORY, CONCURRENT DISEASES, CONCOMITANT MEDICATION, HISTORY OF ALLERGIES OR PREVIOUS FILLER TREATMENTS. THE PATIENT WAS NOT PREGNANT. ON (B)(6) 2017 IN THE LATE AFTERNOON, THE PATIENT RECEIVED TREATMENT WITH 0.9ML RESTYLANE LIDOCAINE (LOT UNKNOWN) TO NOSE WITH UNKNOWN NEEDLE AND UNKNOWN TECHNIQUE, TO IMPROVE THE NOSE CONTOURING SHAPE. ON (B)(6) 2017, THE DAY AFTER THE TREATMENT, THE PATIENT CALLED THE REPORTING PHYSICIAN AND STATED THAT SHE EXPERIENCED VISUAL ACUITY REDUCED(VISUAL ACUITY REDUCED) ON THE LEFT EYE, REDNESS(IMPLANT SITE ERYTHEMA) ON THE NOSE AND FEELING OF SORENESS(PAIN). THE DIAGNOSIS WAS ISCHAEMIC DAMAGE, DUE TO A POSSIBLE VASCULAR OCCLUSION(VASCULAR OCCLUSION) AND POTENTIAL EMBOLISM(EMBOLISM), WHICH CAUSED NOT ONLY SKIN DAMAGE BUT ALSO UNILATERAL REDUCTED VISUAL ACUITY. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED PAPILLOEDEMA(PAPILLOEDEMA) ON AN UNKNOWN DATE. TREATMENT FOR THE ADVERSE EVENT INCLUDED UNSPECIFIED ANTIBIOTIC THERAPY [ANTIBIOTICS] AND UNSPECIFIED CORTISONE THERAPY [CORTISONE]. AN EYE EXAMINATION WAS ALSO PERFORMED. THE PATIENT ALSO RECEIVED HYALURONIDASE [HYALURONIDASE] THROUGH INTRACUTANEOUS ROUTE ON (B)(6) 2017, AND ASPIRINA [ACETYLSALICYLIC ACID] AS TREATMENT FOR THE ADVERSE EVENTS. FURTHERMORE, WARM PACK COMPRESSES WERE APPLIED. THE RESULT FROM THE TREATMENTS WAS PATIENT IMPROVEMENT. ON 20-OCT-2017, FOLLOW-UP INFORMATION WAS RECEIVED FROM THE PHYSICIAN BY PHONE. THE PHYSICIAN REPORTED THAT THE VISUAL ACUITY DISORDER HAD NOT YET RESOLVED AT THE TIME OF FU-REPORTING AND THAT THE PATIENT UNDERWENT AN EYE EXAMINATION AGAIN. ON 24-OCT-2017, FOLLOW-UP INFORMATION WAS RECEIVED FROM THE PHYSICIAN. THE PHYSICIAN REPORTED THAT THE PATIENT UNDERWENT TWO EYE EXAMINATIONS WHICH DID NOT REVEAL VASCULAR OCCLUSION (THAT WAS PREVIOUSLY FOUND). THE PHYSICIAN ALSO INFORMED THAT THE EVENT OF PAPILLOEDEMA HAD NOT YET RESOLVED AND THAT THE VISUAL ACUITY ON THE LEFT SIDE WAS REDUCED BUT HAD NOT YET RESOLVED AT THE TIME OF FOLLOW-UP REPORTING. THE PATIENT UNDERWENT CORTISONE THERAPY WITH DELTACORTENE (PREDNISONE) [PREDNISONE], 25MG TWO TIMES IN THE MORNING, AS TREATMENT FOR THE EVENT. AT THE TIME OF THE REPORT, THE EVENTS HAD NOT YET RECOVERED/RESOLVED.

    Additional Manufacturer Narrative · 1

    ENGINEERING EVALUATION: THE EVENTS OF VASCULAR OCCLUSION, EMBOLISM, VISUAL ACUITY REDUCED, IMPLANT SITE ERYTHEMA AND PAIN ARE EXPECTED. THE EVENTS OF PAPILLOEDEMA AND HEADACHE ARE UNEXPECTED AND POSSIBLY RELATED. THESE EVENTS ARE CONSISTENT WITH THE KNOWN RISK FOR VASCULAR OCCLUSION. EYE DISORDERS ARE CLOSELY MONITORED. IT IS STATED IN THE WARNING SECTION IN THE INSTRUCTIONS FOR USE FOR THE RESTYLANE RANGE OF PRODUCTS THAT THE PRODUCT SHOULD NOT BE INJECTED INTRAVASCULARLY. AS FOR OTHER INJECTABLE MEDICAL DEVICES INADVERTENT INJECTION INTO BLOOD VESSELS COULD POTENTIALLY LEAD TO VASCULAR OCCLUSION ISCHEMIA AND NECROSIS. NO CORRECTIVE OR PREVENTIVE ACTION WILL BE INITIATED. MANUFACTURER NARRATIVE: THERE ARE NO INCREASED TRENDS OF MEDICAL COMPLAINTS FOR THE REPORTED LOT NUMBER 15237-1. NO POTENTIAL QUALITY ISSUES HAVE BEEN IDENTIFIED IN THE MANUFACTURING PROCESS OF THE SPECIFIED BATCH, 15237. THE BATCH IS MANUFACTURED AND RELEASED ACCORDING TO GALDERMA (B)(4) QUALITY MANAGEMENT SYSTEM. PHARMACOVIGILANCE COMMENT: THE SERIOUS, EXPECTED EVENTS OF VASCULAR OCCLUSION, EMBOLISM, VISUAL ACUITY REDUCED, AND THE SERIOUS, UNEXPECTED EVENT OF PAPILLOEDEMA WAS CONSIDERED POSSIBLY RELATED TO THE TREATMENT PROCEDURE. THE NON-SERIOUS, EXPECTED EVENTS OF IMPLANT SITE ERYTHEMA AND PAIN, AND THE NON-SERIOUS, UNEXPECTED EVENT OF HEADACHE WERE CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENT. SERIOUS CRITERIA INCLUDED HOSPITALIZATION AND THE NEED FOR SEVERAL MEDICAL INTERVENTIONS TO PREVENT PERMANENT DAMAGE. POTENTIAL ETIOLOGIES FOR THE EVENT OF HEADACHE AND SUBSEQUENT HOSPITALIZATION INCLUDE THE CORRECTIVE TREATMENT WITH CORTISONE. A POTENTIAL CONTRIBUTORY FACTOR TO THE EVENTS INCLUDES INJECTION TECHNIQUE. THIS CASE MEETS THE CRITERIA OF SERIOUSNESS AND CAUSALITY FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES. (B)(4). EXEMPTION NUMBER: E2015005.

    Description of Event or Problem · 1

    CASE REFERENCE NUMBER (B)(4) IS A SPONTANEOUS REPORT SENT ON 16-OCT-2017 BY A PHYSICIAN VIA THE LSO WHICH REFERS TO A FEMALE PATIENT AGED (B)(6) YEARS. THIS NARRATIVE IS ALSO BASED ON FOLLOW-UP INFORMATION RECEIVED ON 20-OCT-2017 AND 24-OCT-2017 FROM THE PHYSICIAN. NO INFORMATION WAS PROVIDED ABOUT THE PATIENT'S MEDICAL HISTORY, CONCURRENT DISEASES, CONCOMITANT MEDICATION, HISTORY OF ALLERGIES OR PREVIOUS FILLER TREATMENTS. THE PATIENT WAS NOT PREGNANT. ON (B)(6) 2017 IN THE LATE AFTERNOON, THE PATIENT RECEIVED TREATMENT WITH 0.9ML RESTYLANE LIDOCAINE (LOT 15237-1, EXPIRY DATE 31-JAN-2020) TO NOSE INTRADERMALLY USING A STERILE 30G NEEDLE AND UNKNOWN TECHNIQUE, TO IMPROVE THE NOSE CONTOURING SHAPE. IT WAS SPECIFIED THAT THE TREATMENT WAS PERFORMED WITHOUT CAUSING ANY ISSUES IN THE BEGINNING. THE FOLLOWING FIVE HOURS AFTER THE TREATMENT, ON (B)(6) 2017, THE PATIENT CALLED THE PHYSICIAN AND REPORTED PAIN/FEELING OF SORENESS(PAIN) ON THE LEFT PERIORBITAL SIDE AND REDUCTION OF EXTERNAL PERIPHERAL VISUAL FIELD/VISUAL ACUITY REDUCED(VISUAL ACUITY REDUCED) ON THE LEFT EYE. THE DAY AFTER THE TREATMENT, ON (B)(6) 2017, THE PATIENT CALLED THE REPORTING PHYSICIAN AND STATED THAT SHE EXPERIENCED THE VISUAL ACUITY REDUCED ON THE LEFT EYE, FOLLOWING REDNESS(IMPLANT SITE ERYTHEMA) ON THE NOSE AND FEELING OF SORENESS. THE DIAGNOSIS WAS ISCHAEMIC DAMAGE, DUE TO A POSSIBLE VASCULAR OCCLUSION(VASCULAR OCCLUSION) AND POTENTIAL EMBOLISM(EMBOLISM), WHICH CAUSED NOT ONLY SKIN DAMAGE BUT ALSO UNILATERAL REDUCTED VISUAL ACUITY. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED PAPILLOEDEMA(PAPILLOEDEMA) ON AN UNKNOWN DATE. ON (B)(6) 2017, THE PATIENT WAS EXAMINED BY THE REPORTING PHYSICIAN AND WAS REFERRED TO CARRY OUT AN EYE EXAMINATION PERFORMED BY THREE OCULISTS. TREATMENT FOR THE ADVERSE EVENT INCLUDED UNSPECIFIED ANTIBIOTIC THERAPY [ANTIBIOTICS] AND UNSPECIFIED CORTISONE THERAPY [CORTISONE]. AN EYE EXAMINATION WAS ALSO PERFORMED. THE PATIENT ALSO RECEIVED HYALURONIDASE [HYALURONIDASE] THROUGH INTRACUTANEOUS ROUTE ON (B)(6) 2017, AND ASPIRINA [ACETYLSALICYLIC ACID] AS TREATMENT FOR THE ADVERSE EVENTS. FURTHERMORE, WARM PACK COMPRESSES WERE APPLIED. THE RESULT FROM THE TREATMENTS WAS PATIENT IMPROVEMENT. ONE OF THE CORRECTIVE TREATMENTS PERFORMED BY THE REPORTING PHYSICIAN WAS ALSO APPROVED BY THE THREE OCULISTS (NOT SPECIFIED WHICH ONE). ON 20-OCT-2017, FOLLOW-UP INFORMATION WAS RECEIVED FROM THE PHYSICIAN BY PHONE. THE PHYSICIAN REPORTED THAT THE VISUAL ACUITY DISORDER HAD NOT YET RESOLVED AT THE TIME OF FU-REPORTING AND THAT THE PATIENT UNDERWENT AN EYE EXAMINATION AGAIN. ON 24-OCT-2017, FOLLOW-UP INFORMATION WAS RECEIVED FROM THE PHYSICIAN. THE PHYSICIAN REPORTED THAT THE PATIENT UNDERWENT TWO EYE EXAMINATIONS WHICH DID NOT REVEAL VASCULAR OCCLUSION (THAT WAS PREVIOUSLY FOUND). THE PHYSICIAN ALSO INFORMED THAT THE EVENT OF PAPILLOEDEMA HAD NOT YET RESOLVED AND THAT THE VISUAL ACUITY ON THE LEFT SIDE WAS REDUCED BUT HAD NOT YET RESOLVED AT THE TIME OF FOLLOW-UP REPORTING. THE PATIENT UNDERWENT CORTISONE THERAPY WITH DELTACORTENE (PREDNISONE) [PREDNISONE], 25MG TWO TIMES IN THE MORNING, AS TREATMENT FOR THE EVENT. ON 30-NOV-2017, FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTING PHYSICIAN. ON AN UNKNOWN DATE, THE PATIENT WAS HOSPITALIZED FOR ONE NIGHT DUE TO HEADACHE (HEADACHE), ASSESSED AS RELATED TO THE CORTISONE-BASED THERAPY PRESCRIBED BY THE OCULIST. THE DOSE WAS CONSIDERED TOO HIGH WHICH MADE THE SAME OCULIST WITHDRAW IT. IT WAS ALSO REPORTED THAT THE PATIENT WAS COMPLIANT WITH THE THERAPY AND WAS ALWAYS FOLLOWED-UP BY THE REPORTING PHYSICIAN. AT THE TIME OF THE REPORT, ALL EVENTS WERE RECOVERING EXCEPT FROM THE EVENT OF HEADACHE, WHERE THE OUTCOME WAS UNKNOWN. TRACKING LIST: VERSION 1. FU RECEIVED ON 30-NOV-2017: UPDATED PATIENT'S INITIALS AND AGE, LOT NUMBER, INJECTION DEPTH, NEEDLE USED AND OUTCOME (RECOVERING). ADDED EVENT (HEADACHE), FURTHER INFORMATION REGARDING THE PATIENT'S EYE EXAMINATIONS AND ANOTHER SERIOUS CRITERIA; HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796923 RESTYLANE LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA Q-MED 15237-1

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention