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	Hypersensitivity/Allergic reaction (1907)
Date of Event	06/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, the case was assessed as reportable to the us fda as the event of hypersensitivity reaction was deemed to meet serious injury 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 dermal filler lot number 100117959 was reviewed.No nonconformances were noted that would have contributed to these events.A lot search was conducted on the reported lot number and no previous reports had been received on this lot number.
Event or Problem Description
This spontaneous report was received from a medical spa employee via a merz sale representative concerning a (b)(6) female patient who received radiesse.Relevant medical history and concomitant medications were not reported.On (b)(6) 2019, the patient was injected with one (1) syringe of radiesse to an unspecified location.On an unspecified date post injection, the patient experienced a hypersensitivity reaction to radiesse with lower face swelling.It was reported that the patient was seen on (b)(6) 2019 and the lower face swelling was observed.Treatment and outcome were not reported.The lot number was reported as 100117959 with an expiry date of 27 february 2022.Follow up information was received on 23 september 2019 from the reporter.The patient's relevant medical history included prior fillers, not further specified.There were no relevant concomitant medications.The injector was a physician.On (b)(6) 2019 the patient experienced the injection area was red, swollen, warm and not too hard to touch.No laboratory testing was done.Treatment included steroid dosepak and keflex 500mg twice daily (bid) for eight (8) days starting (b)(6) 2019.An additional medrol dosepak was ordered for the patient on (b)(6) 2019 as the swelling was slow to decrease.Exilis radiofrequency treatment was used to help with the swelling.The events resolved in two (2) weeks with an unknown resolution date.The physician assessed that the events were not permanent; however, treatment was necessary to prevent permanent damage.In the medical opinion of the physician, the events were related to the use of 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
• MDR Report Key: 9131668
• Report Number: 3013840437-2019-00004
• Device Sequence Number: 3069835
• Product Code: LMH
• UDI-Device Identifier: M2138071M0K25
• UDI-Public: +M2138071M0K25/$$32202271001179592
• 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
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/27/2022
• Device Model Number: 8071M0K2
• Device Catalogue Number: 8071M0K2
• Device Lot Number: 100117959
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 09/27/2019
• 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: 39 YR