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U.S. Department of Health and Human Services

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

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MERZ NORTH AMERICA, INC. RADIESSE INJECTABLE IMPLANT IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
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.
 
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Brand NameRADIESSE INJECTABLE IMPLANT
Type of DeviceIMPLANT, 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 Key7425430
MDR Text Key105289221
Report Number2135225-2018-00015
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
PMA/PMN Number
P050052
Number of Events Reported1
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 Received04/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/16/2019
Device Catalogue Number8071M6
Device Lot Number100097935
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/29/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/16/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/12/2018 Patient Sequence Number: 1
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