MAUDE Adverse Event Report: MERZ NORTH AMERICA RADIESSE DERMAL FILLER; INJECTABLE IMPLANT

Catalog Number	8071M0K1
Health Effect - Clinical Codes	Swelling (2091); Reaction (2414)
Date of Event	03/20/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was assessed as reportable to the fda as the adverse events, swelling to the upper face and eyes swelling shut, were 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 radiesse dermal filler lot #100086969 was reviewed.No noncomformances were noted that would have contributed to this event.A lot search was conducted on the reported lot and no similar events were noted.Device not returned to manufacturer.
Event or Problem Description
On (b)(6) 2016, a (b)(6) female patient was injected with 1.5cc of radiesse to the cheeks.On an unspecified date post injection, patient experienced swelling to the upper face, and her eyes were swollen shut.She went to either her primary care physician or the emergency room and was given a steroid shot.On (b)(6) 2016, patient returned to injector's office and the swelling was 80% resolved, but her skin was still very tight.She was given aquaphor to apply topically.Patient was contacted by the injector's office today, (b)(6) 2016, and reported the swelling is completely resolved.

• Brand Name: RADIESSE DERMAL FILLER
• Common Device Name: INJECTABLE IMPLANT
• Manufacturer (Section D): MERZ NORTH AMERICA; 4133 courtney road; franksville WI 53126
• MDR Report Key: 5670108
• Report Number: 2135225-2016-00008
• Device Sequence Number: 946457
• Product Code: LMH
• UDI-Device Identifier: M2138071M0K15
• UDI-Public: +M2138071M0K15/$$31812311000869698
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/29/2016

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: Nurse
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 8071M0K1
• Device Lot Number: 100086969
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2016
• Initial Report FDA Received Date: 05/20/2016
• 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: DYSPORT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR