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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
Catalog Number 8071M26K1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Angioedema (4536)
Event Date 05/17/2021
Event Type  Injury  
Manufacturer Narrative
This case was assessed as reportable to the fda as the event, angioedema (pt: angioedema) 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 for radiesse lot number a00006550 was reviewed. A lot search was conducted on the reported lot and no other similar events were noted. No nonconformances were noted that would have contributed to this event.
 
Event Description
This spontaneous report was received from a russian physician and concerns a (b)(6) year-old female patient. She was injected subcutaneously, with a total of 1. 5 ml of radiesse®, into the lower and middle third of the face, for tired morphotype of aging, dermatoporosis and ptosis of the soft tissues of the face, on (b)(6) 2021. The batch number was reported as a00006550. A lot search in the global safety database was conducted. The patient was injected with 0. 75 ml into 4 injection points per side. Needle used for injection was a 25 g cannula. The patient had a laser rejuvenation procedure, one month prior to this report, in (b)(6) 2021. Further patients medical history was reported as none. Concomitant medication included per os colloidal silver solution. She had no disposition to lymph drainage problems, no allergies, autoimmune diseases, intake of interferon or omalizumab, or surgical interventions in the past. Glogau classification was reported as iii. On (b)(6) 2021, after the treatment with radiesse®, the patient experienced an angioedema in the face area. The patient was taken to the hospital by ambulance. As corrective treatment, the patient was given intramuscularly, a solution of dexamethasone (16 mg). The edema significantly decreased in the background of the ongoing therapy. No systemic antibiotic was prescribed. Due to the provided information, the outcome of the event was considered as resolving (reported as not resolved). In the opinion of the reporter, the event was of severe intensity, not life-threatening, unknown if permanent and related to radiesse®.
 
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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 Key11968128
MDR Text Key255180105
Report Number3013840437-2021-00141
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeRS
PMA/PMN Number
P050052
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number8071M26K1
Device Lot NumberA00006550
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2021
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: 06/09/2021 Patient Sequence Number: 1
Treatment
SILVER (SOLUTION)
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