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	Obstruction/Occlusion (2422)
Date of Event	09/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This spontaneous report was received from a us physician and concerns a female patient.She was injected with periosteum depots of radiesse, into the right mandible (off label use of device).Batch number was reported as unknown.A few hours after the radiesse injections on the periosteum, the patient experienced an acute pain and marked swelling with some overlying skin duskiness on the right mandibular area.It appeared consistent with a vascular occlusion (reported as vo).The patient was treated with 300 units of hyaluronidase to site on postoperative day 0 (reported as pod 0).Then repeat treatment on postoperative day 1 (reported as pod 1).Due to persistent pain, as well as nitroglycerin paste, baby aspirin and oral doxycycline.The outcome of the events was unknown.
Additional Manufacturer Narrative
This case was assessed as reportable to the fda, as the event 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 could not be reviewed, as the lot number was not reported.
Event or Problem Description
Follow-up information was received on 19-jul-2024: the events acute pain and swelling/edema was considered as symptoms of vascular occlusion and were therefore not coded.The patient's initials were provided.She was injected with a total of 4.5 ml of radiesse, on (b)(6)2023.Batch number was reported as a00099020 (expiry date: 02/2026).The batch record review was received and the lot number for radiesse was confirmed as a00099020 (expiry date: 02/2026).A lot search in the global safety database was conducted.The patient was previously injected with radiesse, in 2022, without an incident.The patient's medical history included hypothyroid.On (b)(6)2023, after the radiesse injection, the patient experienced a vascular occlusion.Laboratory tests were not performed.An hour after the radiesse injection, the patient complained of an acute pain and an intervention was required to manage potential vascular occlusion.Corrective treatment included (b)(4) of hyaluronidase into the right preauricular and mandibular region, acetylsalicylic acid (asa) 85mg, 1 given several hours after treatment.On (b)(6) 2023, reported as 1 day after the injection, (b)(4) of hyaluronidase and asa 85mg were repeated.Additionally, she was treated with doxycycline 100mg twice daily for 10 days, nitroglycerin ointment twice daily, and red led started and continued for 4 days.Medrol dose pack was started on (b)(6)2023, reported as 2 days after the radiesse injection, due to persistent edema.The outcome of the event was reported as resolved on (b)(6) 2023 (changed from unknown).In the opinion of the reporter, the event was due to radiesse since acute pain occurred at site of injection and it appeared that there was vascular occlusion due to acute pain and persistent swelling, it was not considered to be permanent and an intervention with hyaluronidase aided in resolving the problem.
Additional Manufacturer Narrative
The device history record for radiesse injectable implant, lot number a00099020, 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: 17765256
• Report Number: 3013840437-2023-00102
• Device Sequence Number: 17796668
• Product Code: LMH
• UDI-Device Identifier: M2138071M0K22
• UDI-Public: +M2138071M0K22/$$3260205A00099020$
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Followup
• Report Date (Section B): 07/25/2024

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: 02/05/2026
• Device Catalogue Number: 8071M0K2
• Device Lot Number: A00099020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2023
• Supplement Date Received by Manufacturer: 07/19/2024
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 07/25/2024
• Date Device Manufactured: 02/06/2023
• 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