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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
Lot Number 1001130305
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 possible occlusion (pt: vascular occlusion), was deemed to meet the serious criteria of required intervention to prevent permanent damage. The device history record of radiesse (+) injectable implant could not be reviewed, as the lot number was not reported.
 
Event Description
This spontaneous report was received from a us nurse and concerns a patient. The patient was injected with radiesse(+), into the nasolabial folds, cheeks and tear trough region (off label use of device). After the treatment with radiesse(+), the patient experienced significant swelling and pain when injected into the tear trough. The outcome of the events was unknown. Follow-up information was received on 14-apr-2022: this case was upgraded to serious. The event possible occlusion was added. The events swelling and pain were deleted, they were considered to be symptoms of the reported possible occlusion. After the treatment with radiesse(+), the patient experienced significant swelling in the tear trough area and severe pain. It was further described as a possible 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 Key14167410
MDR Text Key289750104
Report Number3013840437-2022-00058
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
Type of Report Initial,Followup
Report Date 04/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number1001130305
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/21/2022
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: 04/21/2022 Patient Sequence Number: 1
Treatment
CONCOMITANT DRUG NOT AVAILABLE
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