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

Model 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	06/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was assessed as reportable to the fda, as the event 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
This spontaneous report was received from an us health care professional and concerns a patient.The patient was injected with radiesse, into the chin (off label use of device).After the radiesse injection, the patient experienced that it looked like there was an occlusion.The reporter wanted information on how to break down radiesse.As reported, the patient was coming in for follow up on friday.The outcome of the event was unknown.
Event or Problem Description
Follow up information was received on 24-jun-2022: the event term occlusion was amended to vascular occlusion in the mid chin, and the coding remained unchanged.The patients gender (female), weight (about 68 kg) and age were provided.She was 48 years old at the time of the event.The patient was injected with a total of 1.5 ml of radiesse, into the cheeks, cheekbones, jawline and chin.Batch number was reported as a00053300.The batch record review was received and the lot number for radiesse was confirmed as a00053300 (expiry date: 03/2025).A lot search in the global safety database was conducted.A total of 1.5 ml of radiesse was mixed with 5 ml of lidocaine without epinephrine (reported as epi).About 0.5 ml was injected into the chin.She had no previous filler treatments.The patients medical history and concomitant medication were reported as none.On (b)(6) 2022, after the radiesse injection, the patient experienced a vascular occlusion in the mid chin.The reporter evaluated the patient and consulted with a physician over the phone.The chin had good capillary refill, but it was still concerning for an occlusion.The reporter injected 0.1 ml of hylenex mixed with 0.3 ml of saline and massaged the chin with nitro paste for 5 minutes.The patient also sat under a red light-emitting diodes (led) light for 20 minutes.She was prescribed with aspirin 325 mg once daily for 5 days, medrol dosepak for 6 days, cialis 20 mg for 5 days and pentoxifylline 400 mg once daily for 3 days.The patient did not actually take cialis despite it being prescribed.She was advised to massage the area with a warm compress for 5 minutes every 1-2 hours.After friday (b)(6) 2022, the patient significantly improved.On monday (b)(6) 2022, the reporter saw the patient in the office and the chin was much improved in color since friday.The capillary refill times remained good.The patient sent pictures of her chin daily, which improved every day.No laboratory tests were performed.Due to the provided information, the outcome of the event was considered as resolving (changed from unknow to resolving).In the opinion of the reporter, the event was not permanent and was related to radiesse.The reporter did not think treatment was necessary to prevent a permanent damage but did not want to risk it.
Additional Manufacturer Narrative
This case was assessed as reportable to the fda, as the event vascular occlusion in the mid chin (pt: vascular occlusion), was deemed to meet the serious criteria of required intervention to prevent permanent damage.The device history record of radiesse injectable implant, lot number a00053300, was reviewed.A lot search was conducted on the reported lot and no other similar events were noted.No nonconformances were noted that would have contributed to this event.

• 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: 14799901
• Report Number: 3013840437-2022-00089
• Device Sequence Number: 5058429
• Product Code: LMH
• UDI-Device Identifier: M2138071M0K25
• UDI-Public: +M2138071M0K25/$$3250329A00053300$
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P050052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2022

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: 03/29/2025
• Device Model Number: 8071M0K2
• Device Catalogue Number: 8071M0K2
• Device Lot Number: A00053300
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2022
• Supplement Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 06/24/2022
• Supplement Report FDA Received Date: 06/30/2022
• Date Device Manufactured: 03/29/2022
• 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: 48 YR
• Patient Sex: Female
• Patient Weight: 68 KG