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	Urticaria (2278)
Date of Event	08/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was assessed as reportable to the fda, as the event rash/hives (pt: injection site urticaria), was deemed to meet the serious criteria of required intervention to prevent permanent damage.The device history record for radiesse(+) injectable implant, lot a00085940, 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(+), on (b)(6) 2023.In 2023, after the radiesse(+) injection, the patient experienced major swelling in the injection area and random patches up the arm.The outcome of the events was unknown.Follow-up information was received on 27-nov-2023: the case was upgraded to serious.The event term patches was changed to rash/hives and coding was changed from injection site discoloration to injection site hives.The event major swelling was deleted, it was considered to be a symptom of hives.Patients initials, date of birth ((b)(6) ) and weight (62.5 kg) were provided.She was 52 years old at the time of the event.She was injected with 6 syringes of radiesse(+), into the hands and nasolabial folds.Batch number was reported as a00085940 (expiry date: 11/2024).The batch record review was received and the lot number for radiesse(+) was confirmed as a00085940 (expiry date: 11/2024).A lot search in the global safety database was conducted.Patients medical history and concomitant medication were reported as none.The patient had no prior aesthetic treatments.On (b)(6) 2023, 3 days after the radiesse(+) injection, the patient experienced body rashes on the hands and arms as well as her lower cheek area, around the nasolabial folds.She went to the emergency room (er), allergy specialists, and dermatologists and underwent extensive allergy testing.It was narrowed down that she was not allergic to any common elements and that it began after her injections with radiesse(+) and on the area where she was injected with the filler.At the time of this report, she was living day to day with extreme itching and raised bumps (hives) on her hands, arms and face.Laboratory data include allergy testing for common factors such as pollen, animals, dust, et cetera, which all came back negative.The cause of the rash and hives was uncertain and the physician that she saw attributed the symptoms to the filler because they did not find any underlying cause as to her immune system response to any other substance.Corrective treatment included steroid creams, oral antibiotic and antibiotic cream, none of which worked.The patient saw different medical providers across different fields of medicine and side effects were not able to be remedied.Unfortunately, early action and treatment did not help this patient after injections with radiesse(+).The outcome of the event rash/hives was reported as not resolved.In the opinion of the reporter, treatment was necessary to accelerate recovery and prevent permanent damage.The reporter was not certain if the events were permanent, it was almost 4 months (at the time of this report) and it did not subside with diet change and medication.In the opinion of the reporter, the event was 100% related to radiesse(+) (changed from reasonable possibility to highly probable).The reactions started after the injection with radiesse(+) and in the injected areas.

• 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: 18257784
• Report Number: 3013840437-2023-00122
• Device Sequence Number: 4006396
• Product Code: LMH
• UDI-Device Identifier: M2138063M0K22
• UDI-Public: +M2138063M0K22/$$3241114A000859401
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 12/04/2023

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: 11/14/2024
• Device Catalogue Number: 8063M0K2
• Device Lot Number: A00085940
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2023
• Initial Report FDA Received Date: 12/04/2023
• Date Device Manufactured: 11/15/2022
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 63 KG