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

Catalog Number	8063M0K1
Health Effect - Clinical Codes	Cellulitis (1768); Necrosis (1971); Pain (1994); Skin Discoloration (2074); Swelling (2091)
Date of Event	04/04/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was assessed as reportable to the fda as the adverse events of necrosis, cellulitis, and impetigo were deemed to meet serious injury criteria of requiring 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# 100086965 was reviewed.No nonconformances were discovered that would have contributed to these events.A lot search was conducted on lot 100086965 and no similar events were noted.
Event or Problem Description
On (b)(6) 2016, a (b)(6) female patient was injected with one 1.5cc syringe of radiesse+ to the nasolabial folds and 40 units of botox to an unknown area.On the night of (b)(6) 2016, the patient felt more pain and swelling than normal in the injected areas.She applied ice.Within one to two days, patient presented to a walk-in clinic.She was told she may have iced the area too much, causing frost bite.She was referred back to her injector and was seen on (b)(6) 2016.Patient was diagnosed with impetigo and cellulitis and started on keflex and bactroban.The affected area involved the left nasolabial fold, extending about three inches along the fold, up the side of the nose and to the tip edge of the nose.Reporter described the skin as black and dead.Patient was referred to a dermatologist, who suggested patient see a plastic surgeon.The patient started hyperbaric oxygen treatments on an unknown date and has had two treatments.She was seen in follow-up appointments with injector on (b)(6) 2016.On (b)(6) 2016, injector provided patient with samples of cialis 5mg to take once daily.As of patient's last follow up visit with injector, she was doing much better.She was healing.Patient's pre-existing medical conditions reported as none.Patient has been getting injected with fillers for years.Concomitant medication reported as botox.On 21-apr-2016, follow-up information was received from the dermatologist to whom patient was referred.She stated she did not treat the patient.Patient was seen by a plastic surgeon in the dermatologist's office and referred for hyperbaric oxygen treatments due to a diagnosis of skin necrosis.She said they do not have further information about the patient as treatment is being managed through the primary care physician, who was the injector.On 21-apr-2016, follow-up information was received from the injector.Patient's diagnoses were necrosis and cellulitis with superficial impetigo.Treatment reported as hyperbaric oxygen treatments, oral keflex, cialis 5mg, and topical bactroban.
Event or Problem Description
On 08-jun-2016, follow up information was received from the reporter.The patient has not returned for follow-up and the injector's office reported patient has been advised not to speak with them.

• 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: 5659398
• Report Number: 2135225-2016-00014
• Device Sequence Number: 218767
• Product Code: LMH
• UDI-Device Identifier: M2138063M0K15
• UDI-Public: +M2138063M0K15/$$31801061000869655
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2016

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: 01/06/2018
• Device Catalogue Number: 8063M0K1
• Device Lot Number: 100086965
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/20/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/17/2016
• Supplement Report FDA Received Date: 06/22/2016
• 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: 43 YR