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

Catalog Number	8071M0K1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	11/21/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was assessed as reportable to the fda as the event, vascular occlusion, was deemed to meet serious injury criteria of necessitating 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 100093271 was reviewed.No nonconformances were noted that would have contributed to this event.A lot search was conducted on the reported lot and no similar events were noted.
Event or Problem Description
A physician reported that a (b)(6) female patient was injected with radiesse.Medical history and concomitant medications not reported.On (b)(6) 2016, the patient was injected with 0.4 cc of radiesse to the glabella.On (b)(6) 2016, the patient reported erythema, tenderness, and "black area on the skin" near the bridge of the nose.On 22-nov-2016, follow up information was received from the physician.Patient's medical history and concomitant medications clarified as none.On (b)(6) 2016, the patient presented for a follow up appointment with the physician and was diagnosed with a vascular occlusion.Treatment reported as 0.4 ml of hyaluronidase, nitropaste, keflex, valtrex, aspirin, and a medrol dose pack.Patient was instructed to perform massage and apply warm compresses every hour.She was referred to a plastic surgeon, who noted the patient's skin was "ischemic already, the skin was going to die" and advised "normal wound care." causality reported as related.Outcome reported as ongoing.

• 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: 6129033
• Report Number: 2135225-2016-00035
• Device Sequence Number: 19114854
• Product Code: LMH
• UDI-Device Identifier: M2138071M0K15
• UDI-Public: +M2138071M0K15/$$31909061000932711
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P050052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/23/2016

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: Physician
• Device Expiration Date: 09/06/2019
• Device Catalogue Number: 8071M0K1
• Device Lot Number: 100093271
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2016
• Initial Report FDA Received Date: 11/28/2016
• 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: 44 YR