BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA

    MDR report key: 20476749 · Received October 17, 2024

    Report

    Report Number
    1000118068-2024-00026
    Event Type
    Injury
    Date Received
    October 17, 2024
    Date of Event
    April 21, 2024
    Report Date
    October 17, 2024
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    COMPANY COMMENT: THE SERIOUS EVENTS OF GRANULOMA SKIN AND NODULE AT IMPLANT SITE WERE CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENT. SERIOUSNESS CRITERIA INCLUDES THE NEED FOR SURGICAL INTERVENTIONS TO PREVENT PERMANENT DAMAGE. THE POTENTIAL ROOT CAUSE IS THE TREATMENT PROCEDURE OR A FOREIGN BODY REACTION TO THE PRODUCT IN THE LOCAL TISSUE. 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. 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.

    Description of Event or Problem · 0

    CASE REFERENCE NUMBER (B)(4) IS A SPONTANEOUS REPORT SENT ON (B)(6)2024 BY A 34-YEAR-OLD FEMALE PATIENT CONCERNING HERSELF. ADDITIONAL INFORMATION WAS RECEIVED FROM AN OTHER HEALTH PROFESSIONAL ON (B)(6)2024 AND (B)(6)2024. NO INFORMATION ABOUT MEDICAL HISTORY, CONCOMITANT MEDICATION, HISTORY OF ALLERGIES OR PREVIOUS FILLER TREATMENTS HAS BEEN PROVIDED. ON (B)(6)2024, THE PATIENT RECEIVED TREATMENT WITH 2 (UNKNOWN UNITS) OF SCULPTRA TO FACE (UNKNOWN LOT NUMBER, INJECTION TECHNIQUE AND NEEDLE TYPE) AT AN AESTHETIC FACILITY. ONE MONTH AFTER TREATMENT, IN (B)(6)2024, THE PATIENT EXPERIENCED SOME VERY NORMAL PALPABLE NODULES/LUMP (IMPLANT SITE NODULE) ON THE INJECTION SITE. THE PATIENT THOUGHT THE NODULES WOULD RESOLVE ON THEMSELVES. ON (B)(6)2024, THE PATIENT WENT BACK TO THE INJECTOR BECAUSE THE NODULES WERE STILL PRESENT ON THE FACE, AND NO TREATMENT WAS PERFORMED. THEY SAID THAT IT COULD DISSOLVE ITSELF. IN 2024, THE PATIENT WENT TO A DERMATOLOGIST WHO DIAGNOSED IT AS GRANULOMA (GRANULOMA SKIN) AND PERFORMED A SURGERY TO REMOVE THEM FROM FACE. LATER, THE PATIENT ALSO EXPERIENCED NODULES ON THE OTHER SIDE OF THE FACE WHERE SCULPTRA WAS INJECTED. ACCORDING TO HCP, IT WAS NOT A REPORTABLE EVENT. THE PATIENT HAD AN ASSESSMENT POST INJECTION OF SCULPTRA AND HAD A VERY NORMAL, PALPABLE NODULE. THE HCP ASKED HER TO RETURN AFTER ONE MONTH FOR FOLLOW UP BUT PATIENT DECIDED TO GO TO ANOTHER COUNTRY AND HAVE A PHYSICIAN TO REMOVE THE LUMP. THERE WERE NO SAFETY CONCERNS, AND THEY WERE NORMAL RESULTS AFTER TREATMENT. THE HCP STATED THAT NO ONE IN HIS OFFICE OBSERVED ANY ADVERSE EVENTS. OUTCOME AT THE TIME OF THE REPORT: NODULES/LUMP WAS UNKNOWN. GRANULOMA WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1287494 SCULPTRA IMPLANT, DERMAL, FOR AESTHETIC USE LMH Q-MED AB

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Required Intervention