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

Model Number	8071M0K1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swelling (2091)
Date of Event	12/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was assessed as reportable to the fda as the event, severe swelling, was deemed to meet the seriousness criteria of necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.The device history record for radiesse lot number 100123538 was reviewed.A lot search was conducted on the reported lot and no similar events were noted.No non-conformances were noted that would contribute to this event.
Event or Problem Description
This spontaneous report was received from a us healthcare professional and concerns a female patient.She was injected with radiesse® into the hands, on (b)(6) 2019.In (b)(6) 2019, since the treatment with radiesse®, the patient's left hand was swollen and had very unnatural appearance.The patient thought that too much product was injected.The outcome of the event was not reported.Follow-up information was received on 25-feb-2020: this case was upgraded to serious.The events pain with touch and mild erythema were added.The patients initials and date of birth were provided.She was (b)(6) years old.She was injected with a total of 2 ml of radiesse® (1 ml per hand).Batch number was reported as 100123538 (expiry date: 09/2022).The batch record review was received and the lot number for radiesse® was confirmed as 100123538 (exp.09/2022).A lot search in the global safety database was conducted.The patients medical history included breast cancer and thyroid cancer.The patients past medical history included a mastectomy and a lymphadenectomy to the left side.Concomitant medications were reported as none.On (b)(6) 2019, one day after the radiesse® injection, the patient experienced swelling that was severe in nature.The patient also reported pain with touch and mild erythema.The patient was advised to keep the hand elevated above the heart, to perform compression, keep the hand moving to facilitate fluid removal, to perform icing and was prescribed over the counter pain medication.On (b)(6) 2019 the physician saw the patient and the events were fully resolved, reportedly within 2 - 3 weeks after the radiesse® injection.No laboratory tests were performed.In the opinion of the reporter, treatment was necessary to prevent permanent damage, the events were not permanent and related to radiesse®.

• 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
• MDR Report Key: 9875545
• Report Number: 3013840437-2020-00031
• Device Sequence Number: 526461
• Product Code: LMH
• UDI-Device Identifier: M2138071M0K15
• UDI-Public: +M2138071M0K15/$$3220924100123538
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/24/2020

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: 09/24/2022
• Device Model Number: 8071M0K1
• Device Catalogue Number: 8071M0K1
• Device Lot Number: 100123538
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 03/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR