MAUDE Adverse Event Report: MERZ NORTH AMERICA, INC. RADIESSE (+) INJECTABLE IMPLANT; IMPLANT, DERMAL, FOR AESTHETIC USE

Model Number	8063M0K1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Edema (1820)
Date of Event	01/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was assessed as reportable to the fda as the event, facial edema, was deemed to meet the serious injury criteria of necessitating 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 (+) injectable implant lot number 100100295 was reviewed.No nonconformances 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 assistant reported that a (b)(6) female was treated with radiesse (+) injectable implant.This was the patient's first time using the product.On an unknown date, the patient was injected with an unknown amount of radiesse (+) in unspecified site(s).An unknown time post injection, the patient experienced face swelling, swelling in cheeks, around eyes.Additional information was received from the physician assistant on (b)(6) 2018: on (b)(6) 2018, the patient was injected with 1.5 cc radiesse (+) to the midface region.The face had been cleaned prior with hibiclens and arnica was applied after treatment.Shortly after treatment, the patient began to have generalized facial edema to the point her eyes were nearly closed.The patient was treated at the emergency room (er) with solumedrol and was prescribed a medrol dose pack along with cold compresses.As of (b)(6) 2018, the swelling has improved approximately 50%.This was the first time the patient has been injected with dermal filler.Additional information was received from the physician assistant on 31-jan-2018: the patient had a history of allergic reaction to ibuprofen and cortisone injections.Concomitant medication included synthroid.The patient experienced edema in face within one hour of radiesse (+) injections.The patient was seen in er on (b)(6) 2018 and given steroids and benadryl.The event was 50% resolved in four days, 95% resolved by (b)(6) 2018.In the opinion of the reporter, the adverse event was related to the use of radiesse (+).

• Brand Name: RADIESSE (+) INJECTABLE IMPLANT
• Common Device Name: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): MERZ NORTH AMERICA, INC.; 4133 courtney st., suite 10; franksville WI 53126
• MDR Report Key: 7237005
• Report Number: 2135225-2018-00002
• Device Sequence Number: 980102
• Product Code: LMH
• UDI-Device Identifier: M2138063M0K15
• UDI-Public: +M2138063M0K15/$$3190426100100295
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P050052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date (Section B): 02/02/2018

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 Assistant
• Device Expiration Date: 04/26/2019
• Device Model Number: 8063M0K1
• Device Catalogue Number: 8063M0K1
• Device Lot Number: 100100295
• 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: 01/12/2018
• Initial Report FDA Received Date: 02/02/2018
• 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: ARNICA; HIBICLENS; SYNTHROID
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR