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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 8071M5K1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Nodule (4551)
Event Type  Injury  
Manufacturer Narrative
This case was assessed as reportable to the fda as the event, hard lump/solid mass (injection site nodule), was deemed to meet serious injury criteria of necessitated medical or surgical intervention to preclude permanent impairment of a body function or permanent damage of a body structure. The device history record was reviewed, and no similar events were noted. No non-conformances were noted that would have contributed to this event.
 
Event Description
This mdr is related to 3013840437-2020-00124 and 3013840437-2020-00126, referring to the same patient. This spontaneous report was received from a (b)(6) physician and concerns a (b)(6)-year-old female patient. She was injected with radiesse®, in the cheekbone area, and the mandibular arch, 2 months prior to this report, in september 2020. Batch number was reported as 100127924. A lot search in the global safety database was conducted. Radiesse® was injected in vectors. The patient was previously always treated with hyaluronic acid (as reported), with good results and tolerated the treatment well. The patients past medical history included a tumor (some time prior to this report). In 2020, after the treatment with radiesse®, the patient experienced a nodule, further described as an accumulation or a granuloma of radiesse®. After an ultrasound the nodule turned out to be calcium hydroxylapatite. As reported, the patient did not stop touching it since then, even though the physician recommended not to do so. After that, the patient visited another physician who did not resolve anything and she returned to the injecting physician. After two sessions of intra nodular injections with sodium thiosulfate and with trigon, the nodule did not resolve. The patient was also prescribed corticoids. The outcome of the event was reported as not resolved. Follow-up information was received on 20-nov-2020: the case was upgraded to serious. The event nodule / accumulation or a granuloma of radiesse was deleted and the events inflammatory component, hard lump/solid mass, product preparation issue and off label use of device were added. The patient was injected with radiesse® into the left cheek area, with the technique of subcutaneous vectors. Needle used for injection was a 25 g and 50 mm cannula. As reported, radiesse® was diluted in 0. 3 ml of lidocaine 1%, at a dose of 0. 05 ml / by retro-traction technique (product preparation issue, off label use of device). Concomitant medication was reported as none. The patient did not take any medication for prophylaxis. In (b)(6) 2020, one moth after the treatment with radiesse®, during a check up, it was noted, that the patient had a hard lump on the internal face of the left cheek and an inflammatory component around it. It was not painful on palpation and approximately 1x1 cm, with a hard consistency. The physician suspected as a diagnostic impression of granuloma secondary to radiesse® infiltration, and requested an ultrasound scan. The report of the doppler ultrasound showed that the mass that was palpated in mobile left genian region, corresponded to a solid mass that did not capture contrast to the doppler study and that could correspond to a granuloma by the antecedent. It measured 10. 47 mm x 11. 62 mm. No histological examination was performed. The physician initiated the treatment with trigon depot 40 mg intra and perilesional plus a decreasing oral corticoids regimen for 2 weeks. In the revision, the physician injected intralesional thiosulfate na 0. 5 ml and in one week, the granuloma was halved and then the patient was injected again 0. 4 ml intralesional with little result that time. It was reported that in the last revision, about a month and a half after having injected the trigon depot, the patient presented as a complication, lipoatrophy with hypochromic, in the area secondary to the corticoids. The physician started treatment with lidocaine plus physiological serum 5 ml (one dose) that she continued for 4 or 8 weeks. The patient was presenting partial granuloma reduction with lipoatrophy and hypochromia secondary to trigon depot treatment. Due to provided information, the outcome of the event hard lump/solid mass was considered as resolving. The outcome of the remaining events was unknown. Follow-up information was received on 01-dec-2020: the batch record review was received and the lot number for radiesse® was confirmed as 100127924 (expiry date 02/2022).
 
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Brand NameRADIESSE INJECTABLE IMPLANT
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
MERZ NORTH AMERICA, INC.
4133 courtney street
suite 10
franksville WI 53126
Manufacturer (Section G)
MERZ NORTH AMERICA, INC.
4133 courtney street
suite 10
franksville WI 53126
Manufacturer Contact
product safety
6501 six forks road
raleigh, NC 27615
9195828000
MDR Report Key11038738
MDR Text Key223386560
Report Number3013840437-2020-00125
Device Sequence Number1
Product Code LMH
Combination Product (y/n)Y
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 12/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/25/2020
Device Catalogue Number8071M5K1
Device Lot Number100127924
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/20/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/25/2020
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: 12/18/2020 Patient Sequence Number: 1
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