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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 Type  Injury  
Manufacturer Narrative
This case was assessed as reportable to the fda as the event, 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.
 
Event Description
This spontaneous report was received from a us healthcare professional and concerns a patient. The patient was injected with radiesse(+), into the chin (off label use of device). After the treatment with radiesse(+), the patient experienced an occlusion. The outcome of the event was unknown.
 
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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 Key14186446
MDR Text Key289865042
Report Number3013840437-2022-00057
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P050052
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2022
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 Received04/13/2022
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: 04/22/2022 Patient Sequence Number: 1
Treatment
CONCOMITANT DRUG NOT AVAILABLE
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