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	Local Reaction (2035)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was assessed as reportable to the fda, as the event delay hypersensitivity (pt: injection site hypersensitivity), was deemed to meet the serious criteria of required intervention to prevent permanent damage.The device history record for radiesse injectable implant, lot number a00043120, 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.
Event or Problem Description
This spontaneous report was received from a us health care professional and concerns a female patient.She was injected with radiesse hands.The patient went back to work as a house cleaner the day after the treatment with radiesse.After the radiesse injection, the patient experienced late onset of swelling and a feeling of pain.The outcome of the events was unknown.Follow-up information was received on 21-mar-2023: this case was upgraded to serious.The event term late onset of swelling was changed to delay hypersensitivity and the coding was changed from injection site swelling to injection site hypersensitivity.The patients age, date of birth and weight (81.64 kg) were provided.She was 56 years old at the time of the events.She was injected, with a total of 3 ml of radiesse, into the hands, on 21-feb-2023.Batch number was reported as a00043120 (expiry date: 01/2025).A lot search in the global safety database was conducted.The batch record review was received and the lot number for radiesse was confirmed as a00043120 (expiry date: 01/2025).Radiesse 1.5 ml was mixed with 0.2 ml of 1% lidocaine on each hand.She had no previous filler treatments.The patients medical history and concomitant medications were reported as none.The patient had no swelling to hands prior to treatments.In 2023, after the treatment with radiesse, the patient experienced swelling and edema.She continued to experience swelling.At the 2 week mark, the patient had one episode of intense delay, late onset of swelling and reported 5/10 constant pain with sensitivity to the touch.On 06-mar-2023, she was put on one short course of medrol pak which helped with the swelling and pain.The patient was instructed to heat, elevate hands as much as possible and use tylenol or ibuprofen for pain.Patients swelling went down dramatically.On 13-mar-2023, after the patient completed the short course of medrol pak, the swelling returned.On 18-mar-2023, she was prescribed a 10 days course of prednisone 2 mg orally (po) once a day (qd), and advised to use oral antihistamines daily along with heat and tylenol or ibuprofen for pain.After the physician spoke with medical science liaison (msl), the event was diagnosed as delay hypersensitivity.The patients swelling improved with oral steroid.No relevant laboratory tests were performed.The outcome of the event delay hypersensitivity was reported as resolving (changed from unknown).Due to the provided information, the outcome of the event pain was considered as resolving (changed form unknown).In the opinion of the reporter, the event delay hypersensitivity most definitely related to radiesse as both hands had unresolved swelling and edema since the radiesse injection.In the opinion of the reporter they hoped that the event delay hypersensitivity was not going to be permanent and that treatment was required to prevent permanent damage, since the reporter was concerned that the patient continued to experience swelling and that it was going to stay that way.Follow-up information was received on 27-mar-2023: the events lumps and hyperpigmentation discoloration were added.The patients swelling went down and did not return.However, in march 2023, at the time of this report, patient was experiencing two lumps on her right hand.She also reported hyperpigmentation discoloration on both of hands.Due to the provided information, the outcome of the event delay hypersensitivity was considered as resolved, in march 2023 (changed from resolving).The outcome of the event pain was left unchanged.Due to the provided information, the outcome of the event lumps was considered as not resolved.The outcome of the event hyperpigmentation discoloration was unknown.

• 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: 16664457
• Report Number: 3013840437-2023-00036
• Device Sequence Number: 5934260
• Product Code: LMH
• UDI-Device Identifier: M2138071M0K15
• UDI-Public: +M2138071M0K15/$$3250104A00043120S
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/03/2023

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: 01/04/2025
• Device Model Number: 8071M0K1
• Device Catalogue Number: 8071M0K1
• Device Lot Number: A00043120
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 04/03/2023
• Date Device Manufactured: 01/04/2022
• 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 Age: 56 YR
• Patient Sex: Female
• Patient Weight: 81 KG