MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-30 for JUVEDERM VOLLURE XC 2X1 ML 95661 manufactured by Allergan (pringy).
| Report Number | 3005113652-2020-00141 |
| MDR Report Key | 9900525 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-02-10 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PHYSICIAN ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. MICHELLE BURGESS |
| Manufacturer Street | 12331-A RIATA TRACE PARKWAY BUILDING 3 |
| Manufacturer City | AUSTIN TX 78727 |
| Manufacturer Country | US |
| Manufacturer Postal | 78727 |
| Manufacturer Phone | 7372473605 |
| Manufacturer G1 | ALLERGAN (PRINGY) |
| Manufacturer Street | ROUTE DE PROMERY ZONE ARTISANALE DE PRE-MAIRY |
| Manufacturer City | PRINGY 74370 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 74370 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JUVEDERM VOLLURE XC 2X1 ML |
| Generic Name | IMPLANT, DERMAL, FOR AESTHETIC USE |
| Product Code | LMH |
| Date Received | 2020-03-30 |
| Catalog Number | 95661 |
| Lot Number | V17LA90016 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLERGAN (PRINGY) |
| Manufacturer Address | ROUTE DE PROMERY ZONE ARTISANALE DE PRE-MAIRY PRINGY 74370 FR 74370 |
| Brand Name | HYDROCHLORIDE LIDOCAINE / 0.3 % |
| Product Code | --- |
| Date Received | 2020-03-30 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-30 |