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	Cellulitis (1768)
Date of Event	07/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was assessed as reportable to the fda as the adverse event, cellulitis, was deemed to meet serious injury criteria of requiring medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure.The device history record for belotero injectable implant lot 321285 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
A physician reported that a (b)(6) female patient was injected with belotero.Medical history and concomitant medications not reported.On (b)(6) 2017, the patient was injected with one syringe of belotero to the cheeks.On (b)(6) 2017, the patient developed an infection in the left cheek.Treatment reported as unspecified antibiotics and hyaluronidase injection.The infection is resolving.Causality not reported.Lot number reported as 32185.On 19-jul-2017, follow up information was received from the physician.Medical history reported as negative.Concomitant medications reported as unspecified vitamins.On (b)(6) 2017, the patient was injected with voluma "deep" in the cheeks and belotero "on the surface." on (b)(6) 2017, the patient presented with redness, swelling and tenderness to the left cheek and was diagnosed with cellulitis.A mri "the next day" was consistent with cellulitis, without abscess.Treatment reported as intravenous ceftriaxone, administered in the physician's office, and oral cephalexin.The physician believes skin bacteria entered the site during one of the "punctures." on 24-jul-2017, the lot number was clarified to be 321285.

• 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: 6740795
• Report Number: 2135225-2017-00017
• Device Sequence Number: 771488
• Product Code: LMH
• UDI-Device Identifier: M2138700M05
• UDI-Public: +M2138700M05/$$3180622321285E
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P090016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 06/22/2018
• Device Model Number: 8700M0
• Device Catalogue Number: 8700M0
• Device Lot Number: 321285
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2017
• Initial Report FDA Received Date: 07/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: JUVEDERM VOLUMA; UNSPECIFIED VITAMINS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR