MAUDE Adverse Event Report: MERZ NORTH AMERICA, INC RADIESSE INJECTABLE IMPLANT; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number	8071M0K2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cellulitis (1768)
Date of Event	04/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was assessed as reportable to the fda as the event severe cellulitis (injection site cellulitis) was deemed to meet serious injury criteria of required intervention to prevent permanent damage and hospitalization.The device history record of radiesse injectable implant, lot number a00080750, was reviewed.A lot search was conducted on the reported lot and no similar events were noted.Nonconformance reports, corrective/preventive actions related to this lot, but none that would have contributed to this event.
Event or Problem Description
This spontaneous report was received from a us physician and concerns a 55-year-old female patient.She was injected with radiesse, into the mid-face and perioral (off label use of device), for rhytids, volume loss and asymmetry, on (b)(6) 2023.Batch number was reported as a00080750 (expiry date: 07/2025).The batch record review was received and the lot number for radiesse was confirmed as a00080750 (expiry date: 07/2025).As reported she was injected with (b)(4) units of radiesse.She was concomitantly injected with one vial of belotero balance lidocaine, into the mid-face and perioral, for rhytids, volume loss and asymmetry, on (b)(6) 2023.Batch number was reported as e00002280 (expiry date: 12/2023).The patients medical history and concomitant medication were reported as none.On (b)(6) 2023, 1 day after the radiesse injection, the patient experienced a very severe cellulitis.On (b)(6) 2023, the reporter saw the patient and she started the treatment with augmentin.On (b)(6) 2023, she was admitted for intravenous antibiotics for several days.The patient stated culture from affected skin was performed and showed strep.The infection resolved.On (b)(6) 2023, the reporter saw the patient and she had linear scarring visible above right lateral lip area.The outcome of the event severe cellulitis was reported as resolved with sequelae, in 2023.Follow-up information was received on (b)(6) 2023: the patient was injected with 2 vials of radiesse.She has previous history of blepharoplasties and was treated with fillers prior to the visit in question.Off-label use of device was deleted.It was reported that the culture from vesicle on face showed strep growth.It was clarified that the patient was injected with radiesse in the nasolabial area and belotero balance lidocaine injected around the mouth (as reported).The patient declined application of the sterile serum usually used after the procedure and instead applied her own arnica cream which she retrieved from her purse at this visit.The outcome of the event remained unchanged.In the opinion of the reporter, the event was likely related to radiesse, since most evident swelling and infection signs occurred in the right nasolabial area where radiesse was injected, and not around the mouth where belotero balance lidocaine was injected.

• Brand Name: RADIESSE INJECTABLE IMPLANT
• Common Device Name: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): MERZ NORTH AMERICA, INC; 4133 courtney street; suite 10; franksville WI 53126
• Manufacturer (Section G): MERZ NORTH AMERICA, INC; 4133 courtney street; suite 10; franksville WI 53126
• Manufacturer Contact: product safety ; 6501 six forks rd; raleigh, NC 27615 ; 9195828000
• MDR Report Key: 17712747
• Report Number: 3013840437-2023-00090
• Device Sequence Number: 17825314
• Product Code: LMH
• UDI-Device Identifier: M2138071M0K22
• UDI-Public: +M2138071M0K22/$$3250726A000807503
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P050052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/26/2025
• Device Catalogue Number: 8071M0K2
• Device Lot Number: A00080750
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2023
• Initial Report FDA Received Date: 09/08/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BELOTERO BALANCE LIDOCAINE US.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female