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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERZ NORTH AMERICA, INC. RADIESSE; IMPLANT, DERMAL, FOR AESTHETIC USE
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MERZ NORTH AMERICA, INC. RADIESSE; IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
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, nodules, was deemed to meet serious injury criteria of resulted in 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 case was linked to mdr 3013840437-2020-00129, referring to the same reporter and the same reaction.This spontaneous report was received from a us physician and concerns a female patient.She was injected by another injector with radiesse®.After the treatment with radiesse®, the patient experienced nodules.As reported, the patient experienced permanent damage.The outcome of the event was unknown.
 
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Brand Name
RADIESSE
Type of Device
IMPLANT, 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 Key11100359
MDR Text Key224598392
Report Number3013840437-2020-00130
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 health professional
Type of Report Initial
Report Date 12/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Date Manufacturer Received12/02/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
CONCOMITANT DRUG NOT AVAILABLE
Patient Outcome(s) Disability;
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