BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE REFYNE

    MDR report key: 7057251 · Received November 23, 2017

    Report

    Report Number
    9710154-2017-00099
    Event Type
    Injury
    Date Received
    November 23, 2017
    Date of Event
    October 27, 2017
    Report Date
    December 21, 2017
    Manufacturer
    GALDERMA Q-MED
    Product Code
    LMH
    PMA / PMN Number
    P140029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTING EXEMPTION NUMBER: E210500. (B)(4). CAPA: NO CORRECTIVE OR PREVENTIVE ACTION WILL BE INITIATED. THE EVENTS OF SWELLING, IMPLANT SITE PAIN, IMPLANT SITE NODULES, IMPLANT SITE ABSCESS, IMPLANT SITE INFLAMMATION, IMPLANT SITE DISCOLOURATION AND PRURITUS ARE EXPECTED FOR BOTH TREATMENTS. THE EVENTS OF IMPLANT SITE WARMTH AND FATIGUE ARE UNEXPECTED AND POSSIBLY RELATED TO THE TREATMENTS. IT IS STATED IN THE PRECAUTIONS SECTION IN THE INSTRUCTIONS FOR USE FOR THE RESTYLANE RANGE OF PRODUCTS THAT INJECTION PROCEDURES ARE ASSOCIATED WITH A RISK OF INFECTION. ASEPTIC TECHNIQUE AND STANDARD PRACTICE TO PREVENT INFECTION ARE TO BE OBSERVED. MANUFACTURER NARRATIVE: THERE ARE NO INCREASED TRENDS OF MEDICAL COMPLAINTS FOR THE REPORTED LOT NUMBER 15070-1. NO POTENTIAL QUALITY ISSUES HAVE BEEN IDENTIFIED IN THE MANUFACTURING PROCESS OF THE SPECIFIED BATCH 15070. THE BATCH IS MANUFACTURED AND RELEASED ACCORDING TO GALDERMA UPPSALA QUALITY MANAGEMENT SYSTEM. PHARMACOVIGILANCE COMMENTS: THE SERIOUS, EXPECTED EVENT OF ABSCESS AT THE IMPLANT SITE WAS CONSIDERED POSSIBLY RELATED TO THE TREATMENTS. THE NON-SERIOUS, EXPECTED EVENTS OF SWELLING, IMPLANT SITE PAIN, IMPLANT SITE NODULES, IMPLANT SITE INFLAMMATION, IMPLANT SITE DISCOLOURATION, PRURITUS, AND THE NON-SERIOUS, UNEXPECTED EVENTS OF IMPLANT SITE WARMTH AND FATIGUE WERE CONSIDERED POSSIBLY RELATED TO THE TREATMENTS. THE CASE WAS UPGRADED TO SERIOUS STATUS AFTER MEETING THE SERIOUSNESS CRITERIA OF HOSPITALIZATION AND NEED FOR MEDICAL AND SURGICAL INTERVENTION TO PREVENT PERMANENT DAMAGE, INCLUDING THE NEED FOR SURGICAL DRAINAGE, IV ANTIBIOTICS AND CORTISONE TREATMENT. THE CASE REPORT MEETS THE SERIOUSNESS CRITERIA FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES. ADDITIONAL COMMENTS: DEVICE WAS NOT AVAILABLE TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    (B)(4). CAPA: NO CORRECTIVE OR PREVENTIVE ACTION WILL BE INITIATED. THE EVENTS OF SWELLING, PAIN, IMPLANT SITE NODULES, IMPLANT SITE ABSCESS AND IMPLANT SITE INFLAMMATION ARE EXPECTED FOR BOTH TREATMENTS. THE EVENT OF IMPLANT SITE WARMTH IS UNEXPECTED AND POSSIBLY RELATED TO THE TREATMENTS. IT IS STATED IN THE PRECAUTIONS SECTION IN THE INSTRUCTIONS FOR USE FOR THE RESTYLANE RANGE OF PRODUCTS THAT INJECTION PROCEDURES ARE ASSOCIATED WITH A RISK OF INFECTION. ASEPTIC TECHNIQUE AND STANDARD PRACTICE TO PREVENT INFECTION ARE TO BE OBSERVED. MANUFACTURER NARRATIVE: THERE ARE NO INCREASED TRENDS OF MEDICAL COMPLAINTS FOR THE REPORTED LOT NUMBER 14898-2. NO POTENTIAL QUALITY ISSUES HAVE BEEN IDENTIFIED IN THE MANUFACTURING PROCESS OF THE SPECIFIED BATCH 14898. THE BATCH IS MANUFACTURED AND RELEASED ACCORDING TO GALDERMA UPPSALA QUALITY MANAGEMENT SYSTEM. PHARMACOVIGILANCE COMMENTS: THE SERIOUS, EXPECTED EVENT OF ABSCESS AT THE IMPLANT SITE WAS CONSIDERED POSSIBLY RELATED TO THE TREATMENTS. THE NON-SERIOUS, EXPECTED EVENTS OF SWELLING, PAIN, IMPLANT SITE NODULES AND IMPLANT SITE INFLAMMATION, AND THE NON-SERIOUS, UNEXPECTED EVENT OF WARMTH AT THE IMPLANT SITE WERE CONSIDERED POSSIBLY RELATED TO THE TREATMENTS. THE CASE WAS UPGRADED TO SERIOUS STATUS AFTER MEETING THE SERIOUSNESS CRITERIA OF HOSPITALIZATION AND NEED FOR MEDICAL AND SURGICAL INTERVENTION TO PREVENT PERMANENT DAMAGE, INCLUDING THE NEED FOR SURGICAL DRAINAGE AND IV ANTIBIOTICS. THE CASE REPORT MEETS THE SERIOUSNESS CRITERIA FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES. ADDITIONAL COMMENTS: INITIAL REPORT WAS UPGRADED TO SERIOUS ON (B)(6) 2017 DUE TO THE CASE BEING UPGRADED TO SERIOUS.

    Description of Event or Problem · 1

    CASE REFERENCE NUMBER (B)(4) IS A SPONTANEOUS REPORT SENT ON 23-OCT-2017 BY A DENTIST/PHYSICIAN VIA A SALES REPRESENTATIVE, WHICH REFERS TO A FEMALE AGED (B)(6) YEARS. THIS NARRATIVE ALSO CONTAINS FOLLOW-UP INFORMATION RECEIVED BY THE REPORTING DENTIST ON 25-OCT-2017. IT WAS REPORTED THAT THE PATIENT HAD THYROID PROBLEMS (NOT SPECIFIED). THE PATIENT HAD NO ALLERGIES AND HAD NOT BEEN PREVIOUSLY TREATED WITH HYALURONIC ACID FILLERS. ON (B)(6) 2017, THE PATIENT RECEIVED TREATMENT WITH 1ML (DIVIDED ON BOTH SIDES) RESTYLANE REFYNE (LOT 15070-1) TO THE MARIONETTE LINES WITH PROVIDED NEEDLE AND UNKNOWN TECHNIQUE. THE PATIENT ALSO RECEIVED TREATMENT WITH 1ML OF RESTYLANE SKINBOOSTER VITAL LIDOCAINE (LOT 14898-2) TO MARIONETTE LINES WITH UNKNOWN NEEDLE AND UNKNOWN TECHNIQUE. FOUR MONTHS LATER ON (B)(6) 2017, THE PATIENT EXPERIENCED TWO BUMPS/NODULES(IMPLANT SITE NODULE), ONE ON THE CHIN AND THE OTHER ONE NEAR THE LEFT LIP COMMISSURE. THE SAME DAY, THE PATIENT ALSO EXPERIENCED SWELLING(SWELLING) AT UNKNOWN AREA AND PAIN(IMPLANT SITE PAIN) AT MARIONETTE LINES. ACCORDING TO THE PROVIDED ANATOMICAL SCHEME OF THE TREATMENT AREAS, THE ADVERSE EVENTS WERE AT THE IMPLANT SITE. HOWEVER, ACCORDING TO THE PHYSICIAN THE BUMPS WERE IN A NON-INJECTED AREA. ON (B)(6) 2017, THE SWELLING, PAIN AND NODULES REMAINED. THE PATIENT VISITED A DERMATOLOGIST, WHO PRESCRIBED CLAVAMOX (AMOXICILLIN AND CLAVULANIC ACID) [CLAVULANATE POTASSIUM][AMOXICILLIN SODIUM] AS TREATMENT FOR THE ADVERSE EVENTS, WHICH SHE TOOK FOR 24H AND THEN CHANGED TO CIPROFLOXACIN (CIPROXINA) [CIPROFLOXACIN] WHICH SHE TOOK FOR 8 DAYS. ON (B)(6) 2017 IN THE MORNING, THE REPORTING PHYSICIAN STATED THAT THE PATIENT WAS GETTING WORSE. ON (B)(6) 2017, THE PHYSICIAN REPORTED VIA E-MAIL THAT THE PATIENT WAS WORST THAT DAY AND WENT TO THE HOSPITAL WERE SHE RECEIVED INJECTABLE ANTIBIOTIC [ANTIBIOTICS]. IT WAS ALSO REPORTED THAT THE PATIENT HAD NO DARK AREA AND IT WAS NOT NECROTIC. THE EVENTS LOOKS LIKE AN ABSCESS WITH INFLAMED AND HOT AREA(IMPLANT SITE ABSCESS)(IMPLANT SITE INFLAMMATION)(IMPLANT SITE WARMTH). ON (B)(6) 2017, THE REPORTING PHYSICIAN CALLED THE SALES REPRESENTATIVE TO INFORM THAT THE PATIENT WAS HOSPITALIZED. ON (B)(6) 2017, THE REPORTING PHYSICIAN STATED THAT THE PATIENT WAS ADMINISTERED ANOTHER UNSPECIFIED ANTIBIOTIC [ANTIBIOTICS] ON DAY 6 (PROBABLY (B)(6) 2017) AT THE HOSPITAL. AT DAY 9 ((B)(6) 2017) DRAINAGE WITH PUNCTURE WAS PERFORMED AND SENT FOR ANALYSIS, AND ONLY THEN THE PATIENT IMPROVED. THE RESULTS HAVE NOT YET BEEN RECEIVED. THE PHYSICIAN ALSO MENTIONED THAT AFTER THE TREATMENTS WITH RESTYLANE REFYNE AND RESTYLANE SKINBOOSTER VITAL LIDOCAINE, NO OTHER TREATMENTS OR PROCEDURES WERE PERFORMED IN THE ADVERSE EVENTS AFFECTED AREA. ON 10-NOV-2017, THE PHYSICIAN REPORTED TO THE SALES REPRESENTATIVE VIA PHONE THAT THE PATIENT WAS ALMOST RECOVERED AND THAT SHE WAS DISCHARGED FROM THE HOSPITAL ABOUT 3-4 DAYS AGO (THE REPORTER DID NOT SPECIFY A PRECISE DATE). ON 22-NOV-2017, FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTING PHYSICIAN. THE PATIENT WAS MUCH BETTER, HOWEVER, SHE WAS FEELING VERY FATIGUE(FATIGUE) AND HAD OCCASIONAL PAIN AT THE AREA. ADDITIONALLY, SHE HAD A DARKENED AREA(IMPLANT SITE DISCOLOURATION) AT THE MARIONETTE LINES AND STILL HAD SOME LUMPS. THE PATIENT ALSO EXPERIENCED PRURITUS(PRURITUS) AND CONTINUED WITH CORTISONE MEDICATION [CORTISONE]. THE REPORTING PHYSICIAN WAS STILL WAITING FOR THE DRAINAGE RESULTS. THE PATIENT HAS BEEN MONITORED AND HAVE FOLLOW-UP CONSULTATIONS SCHEDULED. OUTCOME AT THE TIME OF THE REPORT: TWO BUMPS/NODULES WAS NOT RECOVERED/NOT RESOLVED. SWELLING WAS RECOVERING/RESOLVING. PAIN WAS NOT RECOVERED/NOT RESOLVED. LOOKS LIKE AN ABSCESS WITH INFLAMED AND HOT AREA WAS RECOVERING/RESOLVING. FATIGUE WAS NOT RECOVERED/NOT RESOLVED. DARKENED AREA WAS NOT RECOVERED/NOT RESOLVED. PRURITUS WAS NOT RECOVERED/NOT RESOLVED.

    Description of Event or Problem · 1

    (B)(4) IS A SPONTANEOUS REPORT SENT ON (B)(6) 2017 BY A DENTIST/PHYSICIAN VIA A SALES REPRESENTATIVE, WHICH REFERS TO A FEMALE (B)(6). THIS NARRATIVE ALSO CONTAINS FOLLOW-UP INFORMATION RECEIVED BY THE REPORTING DENTIST ON (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT HAD THYROID PROBLEMS (NOT SPECIFIED). THE PATIENT HAD NO ALLERGIES AND HAD NOT BEEN PREVIOUSLY TREATED WITH HYALURONIC ACID FILLERS. ON (B)(6) 2017, THE PATIENT RECEIVED TREATMENT WITH 1 ML (DIVIDED ON BOTH SIDES) RESTYLANE REFYNE (LOT 15070-1) TO THE MARIONETTE LINES WITH PROVIDED NEEDLE AND UNKNOWN TECHNIQUE. THE PATIENT ALSO RECEIVED TREATMENT WITH 1 ML OF RESTYLANE SKINBOOSTER VITAL LIDOCAINE (LOT 14898-2) TO MARIONETTE LINES WITH UNKNOWN NEEDLE AND UNKNOWN TECHNIQUE. FOUR MONTHS LATER ON (B)(6) 2017, THE PATIENT EXPERIENCED TWO BUMPS/NODULES(IMPLANT SITE NODULE), ONE ON THE CHIN AND THE OTHER ONE NEAR THE LEFT LIP COMMISSURE. THE SAME DAY, THE PATIENT ALSO EXPERIENCED SWELLING(SWELLING) AND PAIN(PAIN) AT UNKNOWN AREA. ACCORDING TO THE PROVIDED ANATOMICAL SCHEME OF THE TREATMENT AREAS, THE ADVERSE EVENTS WERE AT THE IMPLANT SITE. HOWEVER, ACCORDING TO THE PHYSICIAN THE BUMPS WERE IN A NON-INJECTED AREA. ON (B)(6) 2017, THE SWELLING, PAIN AND NODULES REMAINED. THE PATIENT VISITED A DERMATOLOGIST, WHO PRESCRIBED CLAVAMOX (AMOXICILLIN AND CLAVULANIC ACID) [CLAVULANATE POTASSIUM][AMOXICILLIN SODIUM] AS TREATMENT FOR THE ADVERSE EVENTS, WHICH SHE TOOK FOR 24H AND THEN CHANGED TO CIPROFLOXACIN (CIPROXINA) [CIPROFLOXACIN] WHICH SHE TOOK FOR 8 DAYS. ON (B)(6) 2017 IN THE MORNING, THE REPORTING PHYSICIAN STATED THAT THE PATIENT WAS GETTING WORSE. ON (B)(6) 2017, THE PHYSICIAN REPORTED VIA E-MAIL THAT THE PATIENT WAS WORST THAT DAY AND WENT TO THE HOSPITAL WERE SHE RECEIVED INJECTABLE ANTIBIOTIC [ANTIBIOTICS]. IT WAS ALSO REPORTED THAT THE PATIENT HAD NO DARK AREA AND IT WAS NOT NECROTIC. THE EVENTS LOOKS LIKE AN ABSCESS WITH INFLAMED AND HOT AREA(IMPLANT SITE ABSCESS)(IMPLANT SITE INFLAMMATION)(IMPLANT SITE WARMTH). ON (B)(6) 2017, THE REPORTING PHYSICIAN CALLED THE SALES REPRESENTATIVE TO INFORM THAT THE PATIENT WAS HOSPITALIZED. ON (B)(6) 2017, THE REPORTING PHYSICIAN STATED THAT THE PATIENT WAS ADMINISTERED ANOTHER UNSPECIFIED ANTIBIOTIC [ANTIBIOTICS] ON DAY 6 (PROBABLY (B)(6) 2017) AT THE HOSPITAL. AT DAY 9 ((B)(6) 2017?), DRAINAGE WITH PUNCTURE WAS PERFORMED AND SENT FOR ANALYSIS, AND ONLY THEN THE PATIENT IMPROVED. THE RESULTS HAVE NOT YET BEEN RECEIVED. THE PHYSICIAN ALSO MENTIONED THAT AFTER THE TREATMENTS WITH RESTYLANE REFYNE AND RESTYLANE SKINBOOSTER VITAL LIDOCAINE, NO OTHER TREATMENTS OR PROCEDURES WERE PERFORMED IN THE ADVERSE EVENTS AFFECTED AREA. ON (B)(6) 2017, THE PHYSICIAN REPORTED TO THE SALES REPRESENTATIVE VIA PHONE THAT THE PATIENT WAS ALMOST RECOVERED AND THAT SHE WAS DISCHARGED FROM THE HOSPITAL ABOUT 3-4 DAYS AGO (THE REPORTER DID NOT SPECIFY A PRECISE DATE). AT THE TIME OF THE REPORT, THE OUTCOME FOR ALL EVENTS WAS RECOVERING/RESOLVING. TRACKING LIST: VERSION 1. ALL FUS BELOW WERE INCLUDED IN THE SAME VERSION OF THE CASE. FU RECEIVED ON 27-OCT-2017: DEVICE LOCATIONS FOR SUSPECT PRODUCTS, THREE NEW AES (ABSCESS, INFLAMMATION AND WARMTH) AND CORRECTIVE TREATMENTS WITH ANTIBIOTICS WERE PROVIDED. THE CASE WAS UPGRADED TO SERIOUS DUE TO THE NEED FOR MEDICAL INTERVENTION WITH IV ANTIBIOTIC AT THE HOSPITAL. FU RECEIVED ON 30-OCT-2017: TWO UPDATED PATIENT PHOTOS OF THE AFFECTED AREA WERE RECEIVED. FU RECEIVED ON (B)(6) 2017: THE REPORTER INFORMED THAT THE PATIENT WAS HOSPITALIZED AND THEREFORE UPGRADED HIS SERIOUSNESS ASSESSMENT TO SERIOUS. THE SEVERITY OF AES WAS UPDATED TO SEVERE. FU RECEIVED ON 07-NOV-2017: LOT NUMBER FOR SUSPECT PRODUCT RESTYLANE SB VITAL WHICH INCLUDED LIDOCAINE, AND AMOUNT INJECTED WAS PROVIDED. ADDITIONAL CORRECTIVE TREATMENTS WITH OTHER ANTIBIOTIC WAS PERFORMED INCLUDING PUNCTURE AND DRAINAGE. FU RECEIVED ON (B)(6) 2017: THE PATIENT WAS DISCHARGED AND OUTCOME (RECOVERING) FOR THE EVENTS WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836042 RESTYLANE REFYNE IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA Q-MED 15070-1

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R