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

Catalog Number 8071M6

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Ecchymosis (1818)

Event Date 12/06/2017

Event Type  Injury  

Manufacturer Narrative

This case was assessed as reportable to the fda as medical intervention was necessary 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 100097935 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 Description

This spontaneous report was received from a (b)(6) physician and concerns a female patient.She was injected with a total of 2.1 ml of radiesse, for facial filling, into the mental, nasal dorsum and for facial contour, on (b)(6) 2017.Radiesse was injected with 1 ml into the mental, 0.3 ml into the nasal dorsum and 0.8 ml for facial contour.Batch number was reported as 100097935.Needle used for injection was 25g cannula.Radiesse was diluted with 0.6 ml of physiological saline solution.Previous treatments with fillers or with other aesthetic methods were reported as none.The patient was a non-smoker.Further patient's medical history and concomitant medications were reported as none.On (b)(6) 2017, after the treatment with radiesse, the patient developed peripheral ecchymosis (on both sides of the nasal dorsum) with central pallor of the nasal dorsum.Corrective treatment included prednisolone 40 mg, acetylsalicylic acid 200 mg, local injection of hyaluronidase and physiological saline solution 0.9%, radiofrequency and sildenafil 20 mg.Systemic antibiotic was not prescribed.The outcome of the event was reported as resolving.In the opinion of the reporter, the events were not life-threatening, not permanent, and related to radiesse.Follow-up information was received on 20-mar-2018: the reporter confirmed the patient was a female.The onset date for the events was confirmed as (b)(6) 2017.As reported, the patient did not experience a serious deterioration in health state.The outcome of the events was reported as resolved on (b)(6) 2018.Follow up information was received on 29-mar-2018: this case was upgraded to serious.As reported, there was no diagnosis, but the corrective treatment was necessary to prevent permanent damage.

• Brand Name: RADIESSE INJECTABLE IMPLANT
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): MERZ NORTH AMERICA, INC.; 4133 courtney st., suite 10; franksville WI 53126
• Manufacturer (Section G): MERZ NORTH AMERICA, INC.; 4133 courtney st., suite 10; franksville WI 53126
• Manufacturer Contact: scott sykes, md ; 6501 six forks road; raleigh, NC 27615 ; 9195828000
• MDR Report Key: 7425430
• MDR Text Key: 105289221
• Report Number: 2135225-2018-00015
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: M2138071M65
• UDI-Public: +M2138071M65/$$0219100097935O
• Combination Product (y/n): N
• PMA/PMN Number: P050052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 02/16/2019
• Device Catalogue Number: 8071M6
• Device Lot Number: 100097935
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention