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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 Swelling/ Edema (4577)
Event Type  Injury  
Manufacturer Narrative
This case was assessed as reportable to the fda as the event, throat started swelling shut, was deemed to meet serious injury criteria of necessitated medical or surgical intervention to preclude permanent impairment of a body function or permanent damage of a body structure. The device history record could not be reviewed as the lot number was not provided.
 
Event Description
This consumer report was received from a us consumer and concerns a patient. The patient was injected with radiesse(r), into the marionette lines. Within an hour after from the treatment with radiesse(r), the patients throat started swelling shut. The patient left the office and had a one hour drive home. Upon arrival home, the patient took benadryl and continued to take it all night. The patient called the nurse in the morning and an antibiotic was prescribed. The swelling started to diminish. Due to provided information, the outcome of the event was considered as resolving.
 
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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 road
raleigh, NC 27615
9195828000
MDR Report Key11038724
MDR Text Key222631555
Report Number3013840437-2020-00123
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 consumer
Type of Report Initial
Report Date 12/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/19/2020
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 Treatment Data
Date Received: 12/18/2020 Patient Sequence Number: 1
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