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

Catalog Number	8063M0K2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Type of Reportable Event	Serious Injury
Event or Problem Description
This spontaneous report was received from a us health care professional and concerns a female patient (herself).She was injected subdermally with approximately 0.2 ml of radiesse(+) into the marionette lines area (off label use of device).Batch number was reported as a00117970 (expiry date: 06/2025).The batch record review was received and the lot number for radiesse(+) was confirmed as a00117970 (expiry date: 06/2025).A lot search in the global safety database was conducted.A 27 g needle in a retrograde linear thread fashion was used.Radiesse(+) was injected over 3 to 4 linear retrograde threads.After the radiesse(+) injection, the patient experienced a potential vascular occlusion.In the evening, on a day of the injection, the patient contacted the reporter that was wondering if on the injection area was a bruise or potential vascular occlusion.It was believed that was a bruise, however, a follow-up for the patient was suggested.At the time of this report, the reporter believed the treatment of observation to be what was needed.Monitoring and reassessing was also planned on (b)(6) 2023.The outcome of the event was unknown.
Additional Manufacturer Narrative
This case was assessed as reportable to the fda, as the event potential vascular occlusion (pt: vascular occlusion), was deemed to meet the serious criteria of required intervention to prevent permanent damage.The device history record for radiesse(+) injectable implant, lot number a00117970, was reviewed.A lot search was conducted on the reported lot and no other similar events were noted.No nonconformances were noted related to this lot.

• 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: 18398568
• Report Number: 3013840437-2023-00131
• Device Sequence Number: 2772614
• Product Code: LMH
• UDI-Device Identifier: M2138063M0K22
• UDI-Public: +M2138063M0K22/$$3250625A001179707
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P050052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/27/2023

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: 06/25/2025
• Device Catalogue Number: 8063M0K2
• Device Lot Number: A00117970
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 12/27/2023
• Date Device Manufactured: 06/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: CONCOMITANT DRUG NOT AVAILABLE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female