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	Necrosis (1971)
Date of Event	10/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was assessed as reportable to the fda as the event, necrosis, was deemed to meet serious injury criteria of necessitating medical or surgical intervention to preclude impairment of a body function or permanent damage to a body structure.The case was assessed as serious, possibly related.The event of necrosis was assessed as expected/listed based on the us instructions for use leaflet of radiesse.This case was assessed by merz north america.The device history record for radiesse dermal filler lot 100123412 was reviewed.A lot search was conducted on the reported lot and no similar events were noted.No non-conformances were noted that would have contributed to this event.
Event or Problem Description
This spontaneous report was received from a us nurse practitioner (np) and concerns a (b)(6) female patient.The patient was injected with 1.5cc of radiesse to the chin, right oral commissure and right marionette lines on (b)(6) 2019.Lot 100123412 (expiry 09/26/2022).Medical history positive for filler injections 15 years ago.Further medical history reported as none.The patient was injected to the chin without problems.The np then used the fanning technique to inject the oral commissure.The patient put her tongue behind her lip and pushed her lip down.When she did so, there was immediate blanching and the area turned purple.The np started massaging the area.Within one minute, the area became purple.The np asked the physician to come in and assist with the patient.Corrective treatment reported as continued massage, warm compresses, and injection of hylenex (hyaluronidase) without resolution.The area was purple and mottled.Further corrective treatment with nitropaste, aspirin, and injection of sodium thiosulfate (sts) was done.The patient stayed in the office for hours and left that night with the injected area still very dusky but a little better.On (b)(6) 2019, the physician saw the patient and treated her with hylenex and nitropaste, and started her on prednisone.On (b)(6) 2019, the physician saw the patient, who was improving.She still did not have great perfusion to the area and it was still dusky.Additional injections of sts and hylenex were given and massage was performed.The physician then noted a good palpable pulse in the lip.There was a 1-2 cm area on the outside of the lip that appeared necrotic.The patient was referred for hyperbaric oxygen treatment, which she received on (b)(6) 2019 and (b)(6) 2019.The patient developed herpetic blisters on her lip and was started on acyclovir.As follow up, the patient has been face timing the physician and np.On (b)(6) 2019, the patient sent a picture and was improving, clarified as the lip was pink.In the opinion of the np, the inferior labial artery was either compressed or injected.She believes the patient will have a good outcome.

• 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: 9350592
• Report Number: 3013840437-2019-00020
• Device Sequence Number: 16857090
• Product Code: LMH
• UDI-Device Identifier: M2138071M0K25
• UDI-Public: +M2138071M0K25/$$3220926100123412W
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 11/20/2019

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: 09/26/2022
• Device Model Number: 8071M0K2
• Device Catalogue Number: 8071M0K2
• Device Lot Number: 100123412
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 11/20/2019
• 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: 62 YR