Brand Name | JUVEDERM ULTRA XC 1 ML ROW |
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 |
suzanne
wojcik
|
301 w howard lane |
suite 100 |
austin, TX 78753
|
7372473605
|
|
MDR Report Key | 8325110 |
MDR Text Key | 137025657 |
Report Number | 3005113652-2019-00111 |
Device Sequence Number | 1 |
Product Code |
LMH
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | P050047 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
02/11/2019 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 06/30/2020 |
Device Catalogue Number | 94154EC |
Device Lot Number | H24LA80498 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/17/2019 |
Initial Date FDA Received | 02/11/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/11/2018 |
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 |
Patient Outcome(s) |
Other;
|
Patient Age | 65 YR |