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

Model Number	8063M0K2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Wrinkling (2613)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was assessed as reportable to the fda, as the event fine lines appeared worse (pt: skin wrinkling), was deemed to meet the serious criteria of disability or permanent damage.The device history record for radiesse(+) injectable implant, lot number a00061720, 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 mdr is related to mdr 3013840437-2023-00040 referring to the same patient.This spontaneous report was received from a us health care professional and concerns a female patient.The patients initials and date of birth were reported as unknown.She was injected with 3 syringes of radiesse(+), into several areas.Batch number was reported as a00061720 (expiry date: 06/2024).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 a00061720 (expiry date: 06/2024).Radiesse(+) was hyper diluted (product preparation issue, off label use of device).As reported, an off label technique was used.The patient previously used radiesse(+) for years, and was experienced with hyper diluted radiesse (as reported).She never had that problem before.The patients medical history included fine lines.After the treatment with radiesse(+), the patient experienced no improvement and that her skin almost looked worse.She had little to no result and her fine lines appeared worse.Her skin looked very dehydrated.The outcome of the events was unknown.Follow-up information was received on 28-mar-2023: this case was upgraded to serious.The event term little to no result was amended to zero improvement.The coding was changed from device effect decreased to device ineffective.Causality for the events skin wrinkling and condition aggravated were reassessed.The patients initials, age, date of birth and weight (65.77 kg) were provided.She was 56 years old at the time of the events.The patient was injected, with 1.5 ml of radiesse(+), on (b)(6) 2022.Radiesse(+) was hyper diluted with 3 ml of normal saline (ns) into 3 syringes.The patients medical history included postmenopausal.In (b)(6) 2022 (reported as on (b)(6) 2022), after the treatment with radiesse(+), the patient experienced no improvement and that her skin almost looked worse.In (b)(6) 2022, 3 weeks after the injection, the patient returned for a follow-up and looked worse than she did before the injections.Skin looked dried out, wrinkles were more prevalent, and zero improvement was noted.The patient stated her dissatisfaction.There were no laboratory tests.As reported, no injuries or interventions were given or necessary.Due to the provided information, the outcome of the events skin looked very dehydrated, and fine lines appeared worse was considered as not resolved (changed from unknown).The outcome of the event zero improvement remained unchanged.In the opinion of the reporter, the events were 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 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: 16707045
• Report Number: 3013840437-2023-00039
• Device Sequence Number: 19740143
• Product Code: LMH
• UDI-Device Identifier: M2138063M0K25
• UDI-Public: +M2138063M0K25/$$3240609A000617202
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P050052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 04/10/2023

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: 06/09/2024
• Device Model Number: 8063M0K2
• Device Catalogue Number: 8063M0K2
• Device Lot Number: A00061720
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 04/10/2023
• Date Device Manufactured: 06/09/2022
• 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: Disability
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 65 KG