MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,litera report with the FDA on 2019-06-05 for UNKNOWN REVOLVE UNK REVOLVE manufactured by Lifecell.
| Report Number | 1000306051-2019-00089 |
| MDR Report Key | 8670270 |
| Report Source | COMPANY REPRESENTATIVE,LITERA |
| Date Received | 2019-06-05 |
| Date of Report | 2019-05-28 |
| Date Mfgr Received | 2019-04-29 |
| Date Added to Maude | 2019-06-05 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. CHRISTOPHER BELLE |
| Manufacturer Street | 1 MILLENNIUM WAY |
| Manufacturer City | BRANCHBURG NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9089471100 |
| Manufacturer G1 | LIFECELL |
| Manufacturer Street | 1 MILLENNIUM WAY |
| Manufacturer City | BRANCHBURG NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08876 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN REVOLVE |
| Generic Name | SYSTEM, SUCTION, LIPOPLASTY |
| Product Code | MUU |
| Date Received | 2019-06-05 |
| Catalog Number | UNK REVOLVE |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIFECELL |
| Manufacturer Address | 1 MILLENNIUM WAY BRANCHBURG NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-06-05 |