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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 8063M0K2
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Cyst(s) (1800)
Event Type  Injury  
Manufacturer Narrative
This case was assessed as reportable to the fda as the event, cyst or tumor requiring excision, was deemed to meet serious injury criteria of necessitated medical or surgical intervention to preclude a permanent impairment of a body function or permanent damage to a body structure. The device history record for radiesse(+) dermal filler lot 100114680 was reviewed. A lot search was conducted on the reported lot and no similar events were noted. No non-conformances were noted that would have contributed to this event.
 
Event Description
This spontaneous report was received from a us physician and concerns a female patient. The patient was injected with radiesse(+) on (b)(6) 2019 for marionette lines and oral commisure indications. The physician confirmed no radiesse(+) was injected to the lips. After the treatment with radiesse(+), the patient presented for follow-up with a cyst or tumor in her lip. On (b)(6) 2019, the cyst or tumor was surgically excised and was confirmed by pathology to be a "ball of radiesse. " the patient presented for follow up post excision (lip and inside of lip) and reported pain and discomfort. Lot not reported. Outcome reported as ongoing pain. Follow up information was received from staff member of reporter's office on (b)(6) 2019: patient's initials and date of birth were reported. Medical history positive for previous radiesse(+) injections. Concomitant medications reported as none. The (b)(6) year old female patient was injected with two syringes of radiesse(+). Lot number reported as 100114680.
 
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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 Key8537107
MDR Text Key142669317
Report Number2135225-2019-00028
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
Report Date 04/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/29/2020
Device Catalogue Number8063M0K2
Device Lot Number100114680
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/05/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/29/2018
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: 04/22/2019 Patient Sequence Number: 1
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