Brand Name | RADIESSE (+) INJECTABLE IMPLANT |
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 rd |
raleigh, NC 27615
|
9195828000
|
|
MDR Report Key | 14186446 |
MDR Text Key | 289865042 |
Report Number | 3013840437-2022-00057 |
Device Sequence Number | 1 |
Product Code |
LMH
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P050052 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
04/22/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/13/2022 |
Initial Date FDA Received | 04/22/2022 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | CONCOMITANT DRUG NOT AVAILABLE |
Patient Outcome(s) |
Required Intervention;
|