MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-11-16 for 2 PACK REVOLVE FAT PROCESSING SYSTEM RV0002 manufactured by Lifecell.
[129192455]
This mdr is being reported in an abundance of caution as a malfunction that could lead to serious injury due to the report that the device's packaging was compromised, which could impact sterility. The device was not used. The revolve and its packaging is pending return to lifecell for evaluation. To date, the internal investigation into revolve lot 12050 included a review of the reported information, review of the device history records and review of the complaint history records. Investigation results revealed no remarkable findings with no other complaints reported against the lot and no manufacturing deviations or nonconformance's related to the nature of this event. The lot was terminally sterilized within the process parameters and met all qc release criteria. To date, (b)(4) devices released to finished goods for lot 12050 have been distributed. A follow up report will be submitted upon completion of the device evaluation.
Patient Sequence No: 1, Text Type: N, H10
[129192456]
It was reported that upon opening the revolve packaging, it was identified that the clear plastic container was cracked open. The case was completed with a new device. The complaint related device and packaging will be returned for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000306051-2018-00141 |
| MDR Report Key | 8081168 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-11-16 |
| Date of Report | 2018-11-16 |
| Date of Event | 2018-10-19 |
| Date Mfgr Received | 2018-11-19 |
| Device Manufacturer Date | 2017-11-27 |
| Date Added to Maude | 2018-11-16 |
| 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 | 2 PACK REVOLVE FAT PROCESSING SYSTEM |
| Generic Name | SYSTEM, SUCTION, LIPOPLASTY |
| Product Code | MUU |
| Date Received | 2018-11-16 |
| Returned To Mfg | 2018-11-19 |
| Catalog Number | RV0002 |
| Lot Number | 12050 |
| Device Expiration Date | 2019-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-11-16 |