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

Catalog Number	8063M0K1
Health Effect - Clinical Codes	Cellulitis (1768); Edema (1820); Erythema (1840)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was assessed as reportable to the fda as the event, cellulitis, was deemed to meet serious injury criteria of necessitating medical 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 #100081919 was reviewed.No non-conformances were discovered that would have contributed to this event.A lot search was conducted on the reported lot and no similar complaints were noted.
Event or Problem Description
A physician reported via a sales representative that a (b)(6) female received radiesse+ in her hands.Medical history and concomitant medications were not reported.The physician was uncertain of the patient's prior history of fillers.On (b)(6) 2016, the patient was injected with two, 1.5 cc sized, syringes of radiesse+, one syringe into each hand.The physician reported that the patient developed cellulitis in the right hand.The patient was placed on unspecified oral antibiotics.Additional information was received from the physician on 8-mar-2016: the physician reported that the patient experienced edema and erythema in her right hand.Edema did not appear until approximately 12 days post injection.The physician was currently treating the patient with keflex (cephalexin) without improvement.No further information has been received.

• 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: 5547024
• Report Number: 2135225-2016-00005
• Device Sequence Number: 16390920
• Product Code: LMH
• UDI-Device Identifier: M2138063M0K15
• UDI-Public: +M2138063M0K15/$$31705181000819195
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/07/2016

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: 05/18/2017
• Device Catalogue Number: 8063M0K1
• Device Lot Number: 100081919
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2016
• Initial Report FDA Received Date: 04/05/2016
• 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: 49 YR