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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 8063M4K1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Obstruction/Occlusion (2422)
Event Type  Injury  
Event Description
This spontaneous report was received from a mexican physician and concerns a (b)(6) year-old female patient (weight (b)(6) kg, height 158 cm). She was injected with a total of 1. 5 ml of radiesse(+), into the nasolabial folds and malar region, as a cosmetic correction, on (b)(6) 2022 (also ambiguously reported as (b)(6) 2021). The batch number was reported as a00031840 (expiry date: 07/2023). A lot search in the global safety database was conducted. The batch record review was received and the lot number for radiesse(+) was confirmed as a00031840 (expiry date: 07/2023). She was injected subcutaneously into the nasolabial folds. The patient received the covid-19 booster vaccination, 3 weeks prior to the radiesse(+) injection, in (b)(6) 2021. On (b)(6) 2022, 6 hours after the radiesse(+) injection, the patient experienced a burning pain in the left cheek. The physician prescribed aspirin protect and the use of warm compresses, which reduced the pain by 50%. On (b)(6) 2022, 24 hours after the radiesse(+) injection, the patient experienced oedema in the same region (left cheek). Since the patient returned to her country of residence, the treating physician instructed her to see another specialist. According to the patient, the new physician gave her injections in her face, which improved her symptoms. Due to the provided information the outcome of the events was considered as resolving. Follow-up information was received on 19-jan-2022: this case was upgraded to serious. The event vascular lesion of the facial artery/ suspected occlusion was added. The events oedema and burning pain were deleted, as they were considered as symptoms of the vascular lesion of the facial artery. It was confirmed that the patient had her second injection of the covid-19 vaccination. Based on the evolution of the signs and symptoms that the patient presented in the following days, the treating physician considered it to be a vascular lesion of the facial artery. The patient presented pain and unilateral oedema, a change in skin colouring in the distribution of irrigation of the facial artery, and the appearance of a crust in the groove on the chin side. The symptoms described corresponded to a vascular lesion (whether compression or embolisation). The physician suspects occlusion due to a faulty injection technique. Corrective treatment included hyaluronidase injections, massage, prednisone, pentoxyphylline, sildenafil, aspirin protect and warm compresses. As reported, the patient was in the contact with the new physician for 6 days. On (b)(6) 2022, the patient presented adequate reperfusion. On (b)(6) 2022, the treating physician was going to discharge her, since the events were considered as resolved. Due to the provided information, the outcome of the event was considered as resolved, on (b)(6) 2022. The treating physician did not believe there was a link to the recent covid-19 vaccination.
 
Manufacturer Narrative
This case was assessed as reportable to the fda as the event, vascular lesion of the facial artery/suspected occlusion (vascular occlusion) was deemed to meet serious injury criteria of necessitated 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 (+) lot number a00031840 was reviewed. A lot search was conducted on the reported lot and no other similar events were noted. No nonconformance's were noted that would have contributed to this event.
 
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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 rd
raleigh, NC 27615
9195828000
MDR Report Key13359100
MDR Text Key289250128
Report Number3013840437-2022-00008
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
P050052
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 01/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number8063M4K1
Device Lot NumberA00031840
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/19/2022
Was Device Evaluated by Manufacturer? No Answer Provided
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: 01/26/2022 Patient Sequence Number: 1
Treatment
CONCOMITANT DRUG NOT AVAILABLE
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