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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Obstruction/Occlusion (2422)
Event Date 12/14/2021
Event Type  Injury  
Event Description
This spontaneous report was received from (b)(6) health care professional and concerns a female patient. She was injected with radiesse. After the radiesse injection, the patient experienced a vascular occlusion, located nasolabial. The outcome of the event was unknown. Follow-up information was received on 28-dec-2021: the patient was (b)(6) at the time of the event. She was injected with a total of 1. 5 ml of radiesse, into the nasolabial folds and cheeks (off label use of device), on (b)(6) 2021. On (b)(6) 2021, the same day after the radiesse injection, the patient experienced a vascular occlusion over the left nasolabial fold. Corrective treatment included hot compresses, massage, oral azithromycin, oral valacyclovir, oral sildenafil, oral aspirin, topical nitroglycerin and intralesional hyaluronidase. As reported, the outcome of the event was excellent. No relevant laboratory tests were performed. Due to the provided information the outcome of the event was considered as resolving and was therefore was changed from unknown. In the opinion of the reporter, treatment was necessary to prevent a damage, the event was not permanent and was related to radiesse.
 
Manufacturer Narrative
This case was assessed as reportable to the fda as the event, vascular 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 could not be reviewed as the lot number was not reported.
 
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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 Key13172776
MDR Text Key288584070
Report Number3013840437-2021-00257
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
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/17/2021
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: 01/05/2022 Patient Sequence Number: 1
Treatment
CONCOMITANT DRUG NOT AVAILABLE
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