Brand Name | JUVEDERM ULTRA PLUS/30HV (VOLUME UNKNOWN) |
Type of Device | IMPLANT, DERMAL, FOR AESTHETIC USE |
Manufacturer (Section D) |
ALLERGAN (PRINGY) |
route de promery |
zone artisanale de pre-mairy |
pringy 74370 |
FR 74370 |
|
Manufacturer (Section G) |
ALLERGAN (PRINGY) |
route de promery |
zone artisanale de pre-mairy |
pringy 74370 |
FR
74370
|
|
Manufacturer Contact |
michelle
burgess
|
12331-a riata trace parkway |
building 3 |
austin, TX 78727
|
7372473605
|
|
MDR Report Key | 9911477 |
MDR Text Key | 190483796 |
Report Number | 3005113652-2020-00182 |
Device Sequence Number | 1 |
Product Code |
LMH
|
Combination Product (y/n) | N |
PMA/PMN Number | P050047 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
04/01/2020 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | UNK JUVEDERM ULTRAPLUS |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/06/2020 |
Initial Date FDA Received | 04/01/2020 |
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 |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|