SCULPTRA
Report
- Report Number
- 9710154-2023-00055
- Event Type
- Injury
- Date Received
- July 19, 2023
- Date of Event
- January 13, 2023
- Report Date
- July 19, 2023
- Manufacturer
- Q-MED
- Product Code
- LMH
- PMA / PMN Number
- P030050/S042
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
COMPANY COMMENT: THE SERIOUS EVENTS OF NODULE AND OEDEMA AT IMPLANT SITE AND THE NON-SERIOUS EVENT OF IRRITATION AT IMPLANT SITE 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 IS THE TREATMENT PROCEDURE. ALTERNATIVE ETIOLOGIES INCLUDE CONCOMITANT TREATMENTS INNO PLUS AND LDM ULTRASOUND. THE SCULPTRA WAS INTENTIONALLY MISUSED WITH REGARDS TO RECONSTITUTION. THE CASE MEETS THE SERIOUSNESS 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. LOT NUMBER WAS NOT REPORTED, AND THE PRODUCT COULD NOT BE VERIFIED. 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 (B)(6), 2023 BY A PHYSICIAN WHICH REFERS TO A 56-YEAR-OLD FEMALE PATIENT. THE PATIENT HAD FACIAL WRINKLES. NO INFORMATION ABOUT MEDICAL HISTORY, HISTORY OF ALLERGIES OR PREVIOUS FILLER TREATMENTS HAS BEEN PROVIDED. ON (B)(6), 2021, THE PATIENT RECEIVED TREATMENT WITH 1 VIAL OF SCULPTRA TO BILATERAL FRONT CHEEKS (UNKNOWN LOT NUMBER, INJECTION TECHNIQUE AND NEEDLE TYPE). THE SCULPTRA WAS RECONSTITUTED WITH 10 ML OF STERILE WATER [WATER FOR INJECTION] PLUS LIDOCAINE [LIDOCAINE]. THE SCULPTRA WAS RECONSTITUTED WITH 10 ML OF STERILE WATER (INTENTIONAL DEVICE MISUSE). SAME DAY, SHE ALSO RECEIVED TREATMENT WITH INNO PLUS (LIKE A KIND OF MEDICAL DEVICE) TO UNDER EYES, LDM ULTRASOUND TO HER FACE AND 1 AMPOULE IM INJECTION OF DEXAMETHASONE [DEXAMETHASONE]. THE PHYSICIAN ALSO PRESCRIBED ORAL MEDICATIONS RIZABEN [TRANILAST] CAPSULE, CEFACLOR HYDRATE [CEFACLOR MONOHYDRATE] CAPSULE, DONGKOO, MOSA Q [MOSAPRIDE CITRATE] TABLET. ON (B)(6), 2022, THE PATIENT RE-SAW THE PHYSICIAN. SHE COMPLAINED OF IRRITATION (IMPLANT SITE IRRITATION) UNDER HER LEFT EYE. SAME DAY, THE PATIENT ALSO RECEIVED TREATMENT WITH 1 VIAL OF SCULPTRA TO BILATERAL FRONT CHEEKS (UNKNOWN LOT NUMBER, INJECTION TECHNIQUE AND NEEDLE TYPE). THE SCULPTRA WAS RECONSTITUTED WITH 10 ML OF STERILE WATER PLUS LIDOCAINE. SHE WAS ALSO TREATED WITH LDM ULTRASOUND TO HER FACE AND 1 AMPOULE IM INJECTION OF DEXAMETHASONE. THE PHYSICIAN ALSO PRESCRIBED ORAL MEDICATIONS RIZABEN CAPSULE, CEFACLOR HYDRATE CAPSULE, DONGKOO, MOSA Q TABLET. ON (B)(6), 2023, THE PATIENT HAD PRESENTED TO PHYSICIAN WITH PLAQUE NODULES (IMPLANT SITE NODULE) ON THE CHEEKBONES. SHE WAS INJECTED WITH 0.6 ML OF TRIAMCINOLONE [TRIAMCINOLONE] INJECTION (1): UNKNOWN SOLVENT (4) INTO BOTH CHEEKBONES, UNSPECIFIED IV CEPHALOSPORIN ANTIBIOTIC AND ORAL MEDICATION RIZABEN. SHE ALSO RECEIVED CONCOMITANT TREATMENTS; LDM ULTRASOUND TO HER FACE AND 1 AMPOULE IM INJECTION OF DEXAMETHASONE AND BOTOX [BOTULINUM TOXIN TYPE A] TO HER FOREHEAD AND GLABELLA. ON (B)(6), 2023, THE PATIENT HAD RECEIVED LDM ULTRASOUND TO HER FACE AND 1 AMPOULE IM INJECTION OF DEXAMETHASONE. SHE WAS TREATED WITH UNSPECIFIED IV CEPHALOSPORIN ANTIBIOTIC AND HER SWELLING/EDEMA (IMPLANT SITE OEDEMA) IMPROVED SLIGHTLY. ON (B)(6), 2023, SHE HAD RECEIVED TREATMENT WITH LDM ULTRASOUND TO HER FACE. ON (B)(6), 2023, THE PATIENT HAD AGAIN RECEIVED LDM ULTRASOUND TO HER FACE. SHE WAS TREATED WITH UNSPECIFIED IV CEPHALOSPORIN ANTIBIOTICS. THE PATIENT WAS INJECTED WITH 0.5 ML OF TRIAMCINOLONE [TRIAMCINOLONE INJECTION (1): UNKNOWN SOLVENT (4)] TO BOTH CHEEKBONES. THE PHYSICIAN HAD PRESCRIBED ORAL MEDICATIONS 250 MG OF CEFACLO [CEFACLOR] CAPSULE, 5 MG TABLET OF MOSABLE, RIZABEN CAPSULE AND 10 MG TABLET OF SINGULAIR [MONTELUKAST SODIUM]. ON (B)(6), 2023, THE PATIENT HAD RECEIVED LDM ULTRASOUND TO HER FACE BUT SHE COMPLAINED THAT THE TREATMENTS DID NOT WORK. ON (B)(6), 2023, SHE RECEIVED LDM ULTRASOUND TO HER FACE. ON (B)(6), 2023, THE PATIENT HAD RECEIVED LDM ULTRASOUND TO HER FACE. SHE WAS INJECTED 0.5 ML OF TRIAMCINOLONE [TRIAMCINOLONE INJECTION (1): UNKNOWN SOLVENT (4)] TO BOTH CHEEKBONES. ON (B)(6), 2023, THE PATIENT HAD RECEIVED LDM ULTRASOUND TO HER FACE. SHE WAS INJECTED WITH 1 ML OF TRIAMCINOLONE INJECTION [TRIAMCINOLONE (1): UNKNOWN SOLVENT (4)] INTO RIGHT CHEEKBONE. ON (B)(6), 2023, THE PATIENT HAD RECEIVED LDM ULTRASOUND TO HER FACE. THE PHYSICIAN HAD PRESCRIBED ORAL MEDICATIONS OF CAPSULE CEFACLO. ON (B)(6), 2023, THE PATIENT HAD RECEIVED HIGH-FREQUENCY TREATMENT. SHE WAS INJECTED 1 ML OF TRIAMCINOLONE INJECTION [TRIAMCINOLONE (1): UNKNOWN SOLVENT (4)] INTO UNKNOWN AREA(S) OF HER FACE. AT THE TIME OF REPORTING, THE PLAQUE NODULES WERE IN A STATE OF FRAGMENTATION, AND THEY WERE SLIGHTLY IMPROVING. BUT SHE COMPLAINED ABOUT THE LONG TREATMENT TIME. OUTCOME AT THE TIME OF THE REPORT: IRRITATION WAS UNKNOWN. PLAQUE NODULES WAS RECOVERING/RESOLVING. SWELLING/EDMA WAS RECOVERING/RESOLVING. SCULPTRA WAS RECONSTITUTED WITH 10 ML OF STERILE WATER WAS RECOVERED/RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 883385 | SCULPTRA | IMPLANT, DERMAL, FOR AESTHETIC USE | LMH | Q-MED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Female | Required Intervention | BOTOX| CEFACLOR MONOHYDRATE| DEXAMETHASONE| DONGKOO| INNO PLUS| LIDOCAINE| MOSA Q| RIZABEN| STERILE WATER |