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

Model Number	8700M0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Scarring (2061)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was assessed as reportable to the fda as the event was deemed to meet serious injury criteria.The device history record for belotero dermal filler lot 321189 was reviewed.No non-conformances 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
This report is related to 2135225-2018-00007.This spontaneous report was received from a physician and concerns a female patient (age not reported) who was injected with an unspecified merz product on an unspecified date for unspecified indication.(the physician's order history notes orders for both radiesse+ and belotero).Medical history and concomitant medications not reported.An unspecified time post injection, the patient developed necrosis of the tissue in her cheek and nose.Her face was "severely damaged and permanently scarred." causality reported as related.Radiesse+ lot number unknown as physician has more than one lot number in his order history.Belotero lot number is 321189.Treatment and outcome not reported.
Event or Problem Description
Follow up information was received from the physician on (b)(6) 2018: the patient's initials, age (51 years), gender, and weight (160 pounds) were provided.Medical history positive for previous radiesse and juvederm injections.Concomitant medications reported as none.The patient was injected with a portion of a radiesse+ 1.5cc syringe, clarified as less than 1cc to affected area (right).In april 2015, within a couple of days of injection, the patient developed necrosis of cheek and nasal ala with open wounds.Treatment reported as steroids, aspirin (acetylsalicylic acid), wound care, antiviral medicine, and an antibiotic.Wounds treated for 6-8 weeks.Outcome reported as permanent scarring and deformity of right cheek and right nasal ala with hypo-pigmentation.Causality reported as related to radiesse+ and not related to belotero.Radiesse+ lot number reported as 100079776.

• Brand Name: BELOTERO BALANCE
• 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: 7320383
• Report Number: 2135225-2018-00009
• Device Sequence Number: 1606153
• Product Code: LMH
• UDI-Device Identifier: M2138700M05
• UDI-Public: +M2138700M05/$$31601033211899
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P090016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2018

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: 01/03/2016
• Device Model Number: 8700M0
• Device Catalogue Number: 8700M0
• Device Lot Number: 321189
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/22/2018
• Supplement Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 03/07/2018
• Supplement Report FDA Received Date: 04/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 73