RESTYLANE
Report
- Report Number
- 9710154-2024-00029
- Event Type
- Injury
- Date Received
- May 16, 2024
- Date of Event
- March 18, 2024
- Report Date
- June 12, 2024
- Manufacturer
- Q-MED
- Product Code
- LMH
- PMA / PMN Number
- P040024/S140
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
COMPANY COMMENT: THE SERIOUS EVENTS OF OEDEMA AND PAIN AT IMPLANT SITE WERE CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENT. SERIOUSNESS CRITERIA INCLUDES THE NEED FOR MEDICAL INTERVENTION AND HOSPITALIZATION TO PREVENT PERMANENT DAMAGE. THE POTENTIAL ROOT CAUSE IS THE TREATMENT PROCEDURE, PATIENT'S HYPERSENSITIVITY TO THE PRODUCT OR USE OF PRODUCT. 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. THE REPORTED LOT NUMBER WAS VALID AND VERIFIED THE REPORTED PRODUCT. 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 OEDEMA AND PAIN AT IMPLANT SITE WERE CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENT. SERIOUSNESS CRITERIA INCLUDES THE NEED FOR MEDICAL INTERVENTION AND HOSPITALIZATION TO PREVENT PERMANENT DAMAGE. THE POTENTIAL ROOT CAUSE IS THE TREATMENT PROCEDURE OR PATIENT'S HYPERSENSITIVITY TO THE PRODUCT. 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. THE REPORTED LOT NUMBER WAS VALID AND VERIFIED THE REPORTED PRODUCT. A BATCH RECORD REVIEW WAS PERFORMED TO RULE OUT A NON-CONFORMING PRODUCT. NO POTENTIAL QUALITY ISSUES WERE IDENTIFIED IN THE MANUFACTURING PROCESS OF THE SPECIFIED BATCH. THE BATCH WAS MANUFACTURED AND RELEASED ACCORDING TO GALDERMA QUALITY MANAGEMENT SYSTEM. THE INFORMATION IN THIS CASE DOES NOT INDICATE A NON-CONFORMING PRODUCT OR MALFUNCTION. THE PERFORMED INVESTIGATIONS ARE THEREFORE 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 03-MAY-2024 BY AN OTHER HEALTH PROFESSIONAL CONCERNING A FEMALE PATIENT OF AN UNKNOWN AGE. ADDITIONAL INFORMATION WAS RECEIVED ON 06-MAY-2024 FROM THE SAME REPORTER. THIS WAS CASE 1 OF 25 (REPORTED BY THE SAME REPORTER). NO INFORMATION ABOUT MEDICAL HISTORY, CONCOMITANT MEDICATION, HISTORY OF ALLERGIES OR PREVIOUS FILLER TREATMENTS HAS BEEN PROVIDED. THE HEALTHCARE PROFESSIONAL HAD PURCHASED 50 RESTYLANE GEL FILLERS IN (B)(6) 2024 AND THE PATIENT WAS TREATED WITH THE RESTYLANE GEL FROM THIS PURCHASE. IN (B)(6) 2024, THE PATIENT RECEIVED TREATMENT WITH RESTYLANE (LOT 21345-1) TO FILL DARK CIRCLES (UNKNOWN AMOUNT, INJECTION TECHNIQUE AND NEEDLE TYPE). ON (B)(6) 2024, THE PATIENT EXPERIENCED SEVERE/EXTREME EDEMA (IMPLANT SITE OEDEMA) IN THE AREA APPLIED. THE PATIENT WAS EVEN HOSPITALIZED WITH A LOT OF PAIN (IMPLANT SITE PAIN) IN THE REGION. THE PATIENT WAS TAKING UNSPECIFIED MEDICATION AS A CORRECTIVE TREATMENT. OUTCOME AT THE TIME OF THE REPORT: EDEMA WAS UNKNOWN. LOT OF PAIN WAS UNKNOWN.
CASE REFERENCE NUMBER (B)(4) IS A SPONTANEOUS REPORT SENT ON 03-MAY-2024 BY AN OTHER HEALTH PROFESSIONAL CONCERNING A FEMALE PATIENT OF AN UNKNOWN AGE. ADDITIONAL INFORMATION WAS RECEIVED ON 06-MAY-2024 FROM THE SAME REPORTER. THIS WAS CASE 1 OF 25 (REPORTED BY THE SAME REPORTER). NO INFORMATION ABOUT MEDICAL HISTORY, CONCOMITANT MEDICATION, HISTORY OF ALLERGIES OR PREVIOUS FILLER TREATMENTS HAS BEEN PROVIDED. THE HEALTHCARE PROFESSIONAL HAD PURCHASED 50 RESTYLANE GEL FILLERS IN (B)(6) 2024 AND THE PATIENT WAS TREATED WITH THE RESTYLANE GEL FROM THIS PURCHASE. ON AN UNKNOWN DATE IN (B)(6) 2024, THE PATIENT RECEIVED TREATMENT WITH RESTYLANE (LOT 21345-1) TO FILL DARK CIRCLES (UNKNOWN AMOUNT, INJECTION TECHNIQUE AND NEEDLE TYPE). ON (B)(6) 2024, THE PATIENT EXPERIENCED SEVERE/EXTREME EDEMA (IMPLANT SITE OEDEMA) IN THE AREA APPLIED. THE PATIENT WAS EVEN HOSPITALIZED WITH A LOT OF PAIN (IMPLANT SITE PAIN) IN THE REGION. THE PATIENT WAS TAKING UNSPECIFIED MEDICATION AS A CORRECTIVE TREATMENT. OUTCOME AT THE TIME OF THE REPORT: EDEMA WAS UNKNOWN. LOT OF PAIN WAS UNKNOWN. TRACKING LIST: V.0 INITIAL, V.1 BATCH RECORD REVIEW RESULTS WERE RECEIVED ON 17-MAY-2024.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 708170 | RESTYLANE | IMPLANT, DERMAL, FOR AESTHETIC USE | LMH | Q-MED | 21345-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Hospitalization| R |