Brand Name | BELLAFILL |
Type of Device | IMPLANT, DERMAL, FDR AESTHETIC USE |
Manufacturer (Section D) |
|
MDR Report Key | 8861325 |
MDR Text Key | 153427633 |
Report Number | MW5088754 |
Device Sequence Number | 1 |
Product Code |
LMH
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Unknown
|
Type of Report
| Initial |
Report Date |
07/31/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 08/02/2019 |
Was Device Evaluated by Manufacturer? |
No Information
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 36 YR |
Patient Weight | 61 |
|
|