RESTYLANE DEFYNE
Report
- Report Number
- 9710154-2025-00049
- Event Type
- Injury
- Date Received
- September 11, 2025
- Date of Event
- June 8, 2025
- Report Date
- October 8, 2025
- Manufacturer
- Q-MED AB
- Product Code
- LMH
- PMA / PMN Number
- P140029 S050
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
COMPANY COMMENT: THE SERIOUS EVENTS OF INFLAMMATION, INFECTION AT IMPLANT SITE, FOREIGN BODY REACTION AND THE NON-SERIOUS EVENT OF PURULENT DISCHARGE WERE CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENT. SERIOUSNESS CRITERIA INCLUDES THE NEED FOR MULTIPLE MEDICAL INTERVENTIONS TO PREVENT PERMANENT DAMAGE. THE POTENTIAL ROOT CAUSE INCLUDES INJECTION PROCEDURE ASSOCIATED WITH INADEQUATE ASEPTIC TECHNIQUE OR A FOREIGN BODY REACTION TO THE PRODUCT IN THE LOCAL TISSUE. THE RESTYLANE DEFYNE WAS INTENTIONALLY MISUSED WITH REGARDS TO CANNULA SIZE. THE CASE MEETS THE CRITERIA FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES. EVALUATION TEXT: ROUTINE INVESTIGATIONS HAVE BEEN PERFORMED AND PROVIDE SUFFICIENT INFORMATION TO ASSESS THE POTENTIAL ROOT CAUSE AND INDICATE A POSSIBLE ASSOCIATION TO THE TREATMENT PROCEDURE OR THE PRODUCT. THE REPORTED LOT NUMBER 22235-1 WAS VALID AND VERIFIED THE REPORTED PRODUCT. TO DATE, THIS IS THE ONLY MEDICAL COMPLAINT REPORTED FOR THE LOT NUMBER. A FOLLOW-UP ON THE LOT NUMBER HAVE BEEN PERFORMED AND VERIFIED THE PRODUCT IS AUTHENTIC. A BATCH RECORD REVIEW CONFIRMED THAT NO POTENTIAL ISSUES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS OF THE SPECIFIED BATCH. THE BATCH WAS MANUFACTURED AND RELEASED IN ACCORDANCE WITH GALDERMA QUALITY MANAGEMENT SYSTEM. THE INFORMATION IN THIS CASE DOES NOT INDICATE A NON-CONFORMING PRODUCT OR MALFUNCTION. THEREFORE, THE PERFORMED INVESTIGATIONS ARE CONSIDERED ADEQUATE, AND NO ADDITIONAL INVESTIGATIONS WILL BE CONDUCTED. CAPA COMMENT NO CORRECTIVE OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY BASED ON THE OUTCOME OF THE PERFORMED INVESTIGATIONS.
COMPANY COMMENT: THE SERIOUS EVENTS OF INFLAMMATION, INFECTION AT IMPLANT SITE, FOREIGN BODY REACTION AND THE NON-SERIOUS EVENT OF PURULENT DISCHARGE WERE CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENT. SERIOUSNESS CRITERIA INCLUDES THE NEED FOR MULTIPLE MEDICAL INTERVENTIONS TO PREVENT PERMANENT DAMAGE. THE POTENTIAL ROOT CAUSE INCLUDES INJECTION PROCEDURE ASSOCIATED WITH INADEQUATE ASEPTIC TECHNIQUE OR A FOREIGN BODY REACTION TO THE PRODUCT IN THE LOCAL TISSUE. THE RESTYLANE DEFYNE WAS INTENTIONALLY MISUSED WITH REGARDS TO CANNULA SIZE. THE CASE MEETS THE CRITERIA FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES. EVALUATION TEXT: ROUTINE INVESTIGATIONS HAVE BEEN PERFORMED AND PROVIDE SUFFICIENT INFORMATION TO ASSESS THE POTENTIAL ROOT CAUSE AND INDICATE A POSSIBLE ASSOCIATION TO THE TREATMENT PROCEDURE OR THE PRODUCT. THE REPORTED LOT NUMBER 22235-1 WAS VALID AND VERIFIED THE REPORTED PRODUCT. TO DATE, THIS IS THE ONLY MEDICAL COMPLAINT REPORTED FOR THE LOT NUMBER. HOWEVER, IT WAS NOTED THAT THE REPORTED MANUFACTURING DATE 10-MAR-2025 IS INCONSISTENT WITH THE CORRECT MANUFACTURING DATE, WHICH IS 16-FEB-2025. A FOLLOW-UP WILL BE PERFORMED TO VERIFY THIS DISCREPANCY. TO RULE OUT A NON-CONFORMING PRODUCT, A BATCH RECORD REVIEW WILL BE PERFORMED. CAPA COMMENT: NO CORRECTIVE OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY BASED ON THE OUTCOME OF THE CURRENTLY PERFORMED INVESTIGATIONS.
COMPANY COMMENT: THE SERIOUS EVENTS OF INFLAMMATION, INFECTION AT IMPLANT SITE, FOREIGN BODY REACTION AND THE NON-SERIOUS EVENT OF PURULENT DISCHARGE WERE CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENT. SERIOUSNESS CRITERIA INCLUDES THE NEED FOR MULTIPLE MEDICAL AND SURGICAL INTERVENTIONS TO PREVENT PERMANENT DAMAGE. THE POTENTIAL ROOT CAUSE INCLUDES INJECTION PROCEDURE ASSOCIATED WITH INADEQUATE ASEPTIC TECHNIQUE OR A FOREIGN BODY REACTION TO THE PRODUCT IN THE LOCAL TISSUE. THE RESTYLANE DEFYNE WAS INTENTIONALLY MISUSED WITH REGARDS TO CANNULA SIZE. THE CASE MEETS THE CRITERIA FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES. EVALUATION TEXT: ROUTINE INVESTIGATIONS HAVE BEEN PERFORMED AND PROVIDE SUFFICIENT INFORMATION TO ASSESS THE POTENTIAL ROOT CAUSE AND INDICATE A POSSIBLE ASSOCIATION TO THE TREATMENT PROCEDURE OR THE PRODUCT. THE REPORTED LOT NUMBER 22235-1 WAS VALID AND VERIFIED THE REPORTED PRODUCT. TO DATE, THIS IS THE ONLY MEDICAL COMPLAINT REPORTED FOR THE LOT NUMBER. A FOLLOW-UP ON THE LOT NUMBER HAVE BEEN PERFORMED AND VERIFIED THE PRODUCT IS AUTHENTIC. A BATCH RECORD REVIEW CONFIRMED THAT NO POTENTIAL ISSUES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS OF THE SPECIFIED BATCH. THE BATCH WAS MANUFACTURED AND RELEASED IN ACCORDANCE WITH GALDERMA QUALITY MANAGEMENT SYSTEM. THE INFORMATION IN THIS CASE DOES NOT INDICATE A NON-CONFORMING PRODUCT OR MALFUNCTION. THEREFORE, THE PERFORMED INVESTIGATIONS ARE CONSIDERED ADEQUATE, AND NO ADDITIONAL INVESTIGATIONS WILL BE CONDUCTED. CAPA COMMENT: NO CORRECTIVE OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY BASED ON THE OUTCOME OF THE PERFORMED INVESTIGATIONS
CASE REFERENCE NUMBER (B)(4) IS A SPONTANEOUS REPORT SENT ON 14-AUG-2025 BY A PHYSICIAN CONCERNING A 53-YEAR-OLD CAUCASIAN/WHITE FEMALE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 15-AUG-2025 FROM SAME REPORTER. THE MEDICAL HISTORY OF THE PATIENT INCLUDED BREAST CANCER IN 2022 (THREE YEARS AGO FROM THE DATE OF REPORT). THE PATIENT UNDERWENT CANCER SURGERY AND WAS ALSO TREATED WITH CHEMOTHERAPY AND RADIOTHERAPY. CONCOMITANT MEDICATION INCLUDED AN AROMATASE INHIBITOR ANASTROZOLE [ANASTROZOLE]. NO INFORMATION ABOUT HISTORY OF ALLERGIES OR PREVIOUS FILLER TREATMENTS HAS BEEN PROVIDED. ON (B)(6) 2025, THE PATIENT RECEIVED TREATMENT WITH 2 ML OF RESTYLANE DEFYNE (LOT 22235-1), 1 ML TO EACH SIDE OF COMMISSURES USING 22 G CANNULA, AT THE ENTRY POINT THROUGH JOWLS WITH MICROBOLUS TECHNIQUE IN COMMISSURES UNDER STERILE TECHNIQUE. THE RESTYLANE DEFYNE WAS INJECTED USING 22G CANNULA (INTENTIONAL DEVICE MISUSE). THE PATIENT HAD NOT PREVIOUSLY RECEIVED TREATMENT WITH RESTYLANE DEFYNE. ON (B)(6) 2025, THE PATIENT EXPERIENCED AN INFLAMMATORY (IMPLANT SITE INFLAMMATION) NODULE/FOREIGN BODY GRANULOMAS (FOREIGN BODY REACTION) OF PROGRESSIVE GROWTH AND EPISODES OF SUPPURATION WITH A FLOW OF PURULENT MATERIAL (PURULENT DISCHARGE). IN 2025, THE PATIENT ALSO UNDERWENT AN ULTRASOUND SCAN THAT SHOWED THE ABSENCE OF HYALURONIC ACID AND SUGGESTED AN INFECTION (IMPLANT SITE INFECTION). THE REPORTING PHYSICIAN CONFIRMED THAT ONLY THE LEFT COMMISSURE HAD THE SIDE EFFECT. AS THE RESTYLANE DEFYNE INJECTED NEAR THE SCANNED REGION, ON (B)(6) 2025, THE HCP PERFORMED TWO BIOPSIES AND ASPIRATION OF PURULENT SECRETION FROM THE LESION. ONE BIOPSY RESULT SHOWED NO PRESENCE OF HYALURONIC ACID, WHILE THE OTHER SHOWED FOREIGN BODY GRANULOMAS RELATED TO HYALURONIC ACID, WHICH WAS CONFIRMED BY COLLOIDAL IRON STAINING. ON (B)(6) 2025, THE PATIENT UNDERWENT ASPIRATION OF PURULENT SECRETION FROM THE LESION FOR CULTURES AND DIRECT EXAMINATIONS. THE HCP PERFORMED DIRECT SURVEYS AND CULTURES FOR THREE TIMES FOR FUNGI, BACTERIA AND MYCOBACTERIA AND ALL WERE NEGATIVE. IN 2025, THE PATIENT HAD NUMEROUS CONSULTATIONS WITH THE INJECTOR AND OTHER DERMATOLOGISTS DUE TO THE EVENTS. THE PATIENT WAS TREATED WITH FOUR COURSES OF ANTIBIOTICS, INCLUDING DOXYCYCLINE [DOXYCYCLINE], CLINDAMYCIN [CLINDAMYCIN], CEPHALOSPORINS KEFLEX [CEFALEXIN] 500 MG EVERY 6 HOURS FOR 7 DAYS AND ZINNAT [CEFUROXIME AXETIL] 500 MG EVERY 12 HOURS FOR 7 DAYS WHICH SHOWED NO IMPROVEMENT. SHE ALSO RECEIVED TREATMENT WITH CORTICOSTEROID METICORTEN [PREDNISONE] 30 MG A DAY FOR 5 DAYS AND INFILTRATED WITH TRIAMCINOLONE [TRIAMCINOLONE] 2 TIMES IN ANOTHER COUNTRY WITHOUT ANY IMPROVEMENT. THE PATIENT WAS NOT HOSPITALIZED DUE TO THE EVENTS. THE TREATMENTS WITH CLINDAMYCIN, DOXYCYCLINE, AND TRIAMCINOLONE WERE ADMINISTERED IN ANOTHER COUNTRY, OUTSIDE OF BRAZIL. THEREFORE, THE REPORTER DID NOT HAVE INFORMATION REGARDING THE DOSAGE. AT THE TIME OF THE REPORT ON (B)(6) 2025, THE PATIENT HAD NOT RECEIVED ANY ADDITIONAL CORRECTIVE TREATMENTS, AND THE OUTCOME OF THE EVENTS REMAINED ONGOING. THE REPORTING PHYSICIAN ASSESSED EVENTS AS OF SEVERE INTENSITY AND CAUSALITY TO THE TREATMENT AS POSSIBLE. OUTCOME AT THE TIME OF THE REPORT: INFLAMMATORY WAS NOT RECOVERED/NOT RESOLVED/ONGOING. NODULE/FOREIGN BODY GRANULOMAS WAS NOT RECOVERED/NOT RESOLVED/ONGOING. PURULENT MATERIAL WAS NOT RECOVERED/NOT RESOLVED/ONGOING. INFECTION WAS NOT RECOVERED/NOT RESOLVED/ONGOING. RESTYLANE DEFYNE WAS INJECTED USING 22G CANNULA WAS RECOVERED/RESOLVED. TRACKING LIST: V.0 INITIAL V.1 FU RECEIVED ON (B)(6) 2025 FROM THE SAME REPORTER. EVENT LOCATION, OUTCOME, LABORATORY TESTS AND CORRECTIVE TREATMENT DETAILS WERE UPDATED. LOT NUMBER VALIDATION AND BATCH RECORD REVIEW INVESTIGATION RESULTS WERE RECEIVED ON (B)(6) 2025.
CASE REFERENCE NUMBER (B)(4) IS A SPONTANEOUS REPORT SENT ON (B)(6) 2025 BY A PHYSICIAN CONCERNING A 53-YEAR-OLD CAUCASIAN/WHITE FEMALE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 15-AUG-2025 FROM SAME REPORTER. THE MEDICAL HISTORY OF THE PATIENT INCLUDED BREAST CANCER IN 2022 (THREE YEARS AGO FROM THE DATE OF REPORT). THE PATIENT UNDERWENT CANCER SURGERY AND WAS ALSO TREATED WITH CHEMOTHERAPY AND RADIOTHERAPY. CONCOMITANT MEDICATION INCLUDED AN AROMATASE INHIBITOR ANASTROZOLE [ANASTROZOLE]. NO INFORMATION ABOUT HISTORY OF ALLERGIES OR PREVIOUS FILLER TREATMENTS HAS BEEN PROVIDED. ON (B)(6) 2025, THE PATIENT RECEIVED TREATMENT WITH 2 ML OF RESTYLANE DEFYNE (LOT 22235-1), 1 ML TO EACH SIDE OF COMMISSURES USING 22 G CANNULA, AT THE ENTRY POINT THROUGH JOWLS WITH MICROBOLUS TECHNIQUE IN COMMISSURES UNDER STERILE TECHNIQUE. THE RESTYLANE DEFYNE WAS INJECTED USING 22G CANNULA (INTENTIONAL DEVICE MISUSE). THE PATIENT HAD NOT PREVIOUSLY RECEIVED TREATMENT WITH RESTYLANE DEFYNE. ON (B)(6) 2025, THE PATIENT EXPERIENCED AN INFLAMMATORY (IMPLANT SITE INFLAMMATION) NODULE/FOREIGN BODY GRANULOMAS (FOREIGN BODY REACTION) OF PROGRESSIVE GROWTH AND EPISODES OF SUPPURATION WITH A FLOW OF PURULENT MATERIAL (PURULENT DISCHARGE). IN 2025, THE HCP PERFORMED DIRECT SURVEYS AND CULTURES FOR THREE TIMES FOR FUNGI, BACTERIA AND MYCOBACTERIA AND ALL WERE NEGATIVE. THE PATIENT ALSO UNDERWENT AN ULTRASOUND SCAN THAT SHOWED THE ABSENCE OF HYALURONIC ACID AND SUGGESTED AN INFECTION (IMPLANT SITE INFECTION). AS THE RESTYLANE DEFYNE INJECTED NEAR THE SCANNED REGION, ON (B)(6) 2025, THE HCP PERFORMED TWO BIOPSIES. ONE BIOPSY RESULT SHOWED NO PRESENCE OF HYALURONIC ACID, WHILE THE OTHER SHOWED FOREIGN BODY GRANULOMAS RELATED TO HYALURONIC ACID, WHICH WAS CONFIRMED BY COLLOIDAL IRON STAINING. IN 2025, THE PATIENT HAD NUMEROUS CONSULTATIONS WITH THE INJECTOR AND OTHER DERMATOLOGISTS DUE TO THE EVNTS. THE PATIENT WAS TREATED WITH FOUR COURSES OF ANTIBIOTICS, INCLUDING DOXYCYCLINE [DOXYCYCLINE], CLINDAMYCIN [CLINDAMYCIN] AND CEPHALOSPORINS WHICH SHOWED NO IMPROVEMENT. SHE ALSO RECEIVED TREATMENT WITH UNSPECIFIED LOCAL CORTICOSTEROID INFILTRATION, IN ADDITION TO SYSTEMIC CORTICOSTEROIDS WITHOUT ANY IMPROVEMENT. THE PATIENT WAS NOT HOSPITALIZED DUE TO THE EVENTS. THE REPORTING PHYSICIAN ASSESSED EVENTS AS OF SEVERE INTENSITY AND CAUSALITY TO THE TREATMENT AS POSSIBLE. OUTCOME AT THE TIME OF THE REPORT: INFLAMMATORY WAS NOT RECOVERED/NOT RESOLVED/ONGOING. NODULE/FOREIGN BODY GRANULOMAS WAS NOT RECOVERED/NOT RESOLVED/ONGOING. PURULENT MATERIAL WAS NOT RECOVERED/NOT RESOLVED/ONGOING. INFECTION WAS NOT RECOVERED/NOT RESOLVED/ONGOING. RESTYLANE DEFYNE WAS INJECTED USING 22G CANNULA WAS RECOVERED/RESOLVED.
CASE REFERENCE NUMBER (B)(4) IS A SPONTANEOUS REPORT SENT ON (B)(6) 2025 BY A PHYSICIAN CONCERNING A 53-YEAR-OLD CAUCASIAN/WHITE FEMALE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2025 FROM SAME REPORTER. THE MEDICAL HISTORY OF THE PATIENT INCLUDED BREAST CANCER IN 2022 (THREE YEARS AGO FROM THE DATE OF REPORT). THE PATIENT UNDERWENT CANCER SURGERY AND WAS ALSO TREATED WITH CHEMOTHERAPY AND RADIOTHERAPY. CONCOMITANT MEDICATION INCLUDED AN AROMATASE INHIBITOR ANASTROZOLE [ANASTROZOLE]. NO INFORMATION ABOUT HISTORY OF ALLERGIES OR PREVIOUS FILLER TREATMENTS HAS BEEN PROVIDED. ON (B)(6) 2025, THE PATIENT RECEIVED TREATMENT WITH 2 ML OF RESTYLANE DEFYNE (LOT 22235-1), 1 ML TO EACH SIDE OF COMMISSURES USING 22 G CANNULA, AT THE ENTRY POINT THROUGH JOWLS WITH MICROBOLUS TECHNIQUE IN COMMISSURES UNDER STERILE TECHNIQUE. THE RESTYLANE DEFYNE WAS INJECTED USING 22G CANNULA (INTENTIONAL DEVICE MISUSE). THE PATIENT HAD NOT PREVIOUSLY RECEIVED TREATMENT WITH RESTYLANE DEFYNE. ON (B)(6) 2025, THE PATIENT EXPERIENCED AN INFLAMMATORY (IMPLANT SITE INFLAMMATION) NODULE/FOREIGN BODY GRANULOMAS (FOREIGN BODY REACTION) OF PROGRESSIVE GROWTH AND EPISODES OF SUPPURATION WITH A FLOW OF PURULENT MATERIAL/SECRETION (PURULENT DISCHARGE). IN 2025, THE PATIENT ALSO UNDERWENT AN ULTRASOUND SCAN THAT SHOWED THE ABSENCE OF HYALURONIC ACID AND SUGGESTED AN INFECTION (IMPLANT SITE INFECTION). THE REPORTING PHYSICIAN CONFIRMED THAT ONLY THE LEFT COMMISSURE HAD THE SIDE EFFECT. AS THE RESTYLANE DEFYNE INJECTED NEAR THE SCANNED REGION, ON (B)(6) 2025, THE HCP PERFORMED TWO BIOPSIES AND ASPIRATION OF PURULENT SECRETION FROM THE LESION. ONE BIOPSY RESULT SHOWED NO PRESENCE OF HYALURONIC ACID, WHILE THE OTHER SHOWED FOREIGN BODY GRANULOMAS RELATED TO HYALURONIC ACID, WHICH WAS CONFIRMED BY COLLOIDAL IRON STAINING. ON (B)(6) 2025, THE PATIENT UNDERWENT ASPIRATION OF PURULENT SECRETION FROM THE LESION FOR CULTURES AND DIRECT EXAMINATIONS. THE HCP PERFORMED DIRECT SURVEYS AND CULTURES FOR THREE TIMES FOR FUNGI, BACTERIA AND MYCOBACTERIA AND ALL WERE NEGATIVE. IN 2025, THE PATIENT HAD NUMEROUS CONSULTATIONS WITH THE INJECTOR AND OTHER DERMATOLOGISTS DUE TO THE EVENTS. THE PATIENT WAS TREATED WITH FOUR COURSES OF ANTIBIOTICS, INCLUDING DOXYCYCLINE [DOXYCYCLINE], CLINDAMYCIN [CLINDAMYCIN], CEPHALOSPORINS KEFLEX [CEFALEXIN] 500 MG EVERY 6 HOURS FOR 7 DAYS AND ZINNAT [CEFUROXIME AXETIL] 500 MG EVERY 12 HOURS FOR 7 DAYS WHICH SHOWED NO IMPROVEMENT. SHE ALSO RECEIVED TREATMENT WITH CORTICOSTEROID METICORTEN [PREDNISONE] 30 MG A DAY FOR 5 DAYS AND INFILTRATED WITH TRIAMCINOLONE [TRIAMCINOLONE] 2 TIMES IN ANOTHER COUNTRY WITHOUT ANY IMPROVEMENT. THE PATIENT WAS NOT HOSPITALIZED DUE TO THE EVENTS. THE TREATMENTS WITH CLINDAMYCIN, DOXYCYCLINE, AND TRIAMCINOLONE WERE ADMINISTERED IN ANOTHER COUNTRY, OUTSIDE OF BRAZIL. THEREFORE, THE REPORTER DID NOT HAVE INFORMATION REGARDING THE DOSAGE. ON (B)(6) 2025, THE PATIENT HAD NOT RECEIVED ANY ADDITIONAL CORRECTIVE TREATMENTS, AND THE OUTCOME OF THE EVENTS REMAINED ONGOING. IN (B)(6) 2025, THE HCP REPORTED THAT, THERE WAS NO COMPLETE RECOVERY FROM THE NODULE. ADDITIONALLY, THE LOCAL INFLAMMATION BEGAN TO DECREASE IN INTENSITY, AND THE SECRETION BEGAN TO CEASE AFTER THE LAST SPONTANEOUS DRAINAGE WHICH WAS IN LARGE QUANTITY. THE TREATMENT WITH RESTYLANE DEFYNE WAS NOT REINTRODUCED. ON (B)(6) 2025, A PLASTIC SURGEON PERFORMED A SURGICAL CORRECTION WITH A REMOVAL OF THE INFLAMED AREA AND SUTURE. THE REPORTING PHYSICIAN ASSESSED EVENTS AS OF SEVERE INTENSITY AND CAUSALITY TO THE TREATMENT AS POSSIBLE. OUTCOME AT THE TIME OF THE REPORT: INFLAMMATORY WAS RECOVERING/RESOLVING. NODULE/FOREIGN BODY GRANULOMAS WAS NOT RECOVERED/NOT RESOLVED/ONGOING. PURULENT MATERIAL/SECRETION WAS RECOVERING/RESOLVING. INFECTION WAS NOT RECOVERED/NOT RESOLVED/ONGOING. RESTYLANE DEFYNE WAS INJECTED USING 22G CANNULA WAS RECOVERED/RESOLVED. TRACKING LIST: V.0 INITIAL V.1 FU RECEIVED ON (B)(6) 2025 FROM THE SAME REPORTER. EVENT LOCATION, OUTCOME, LABORATORY TESTS AND CORRECTIVE TREATMENT DETAILS WERE UPDATED. LOT NUMBER VALIDATION AND BATCH RECORD REVIEW INVESTIGATION RESULTS WERE RECEIVED ON (B)(6) 2025. V.2 FU RECEIVED ON (B)(6) 2025 FROM THE SAME REPORTER. VERBATIM, OUTCOME OF EVENTS AND CORRECTIVE TREATMENT DETAILS WERE UPDATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2232868 | RESTYLANE DEFYNE | IMPLANT; DERMAL; FOR AESTHETIC USE | LMH | Q-MED AB | 22235-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Female | Required Intervention |