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 2018-11-06 for UNKNOWN REVOLVE UNK REVOLVE manufactured by Lifecell.
[126243209]
This mdr is being reported in an abundance of caution as serious injury due to the assumed medical or surgical intervention to treat the patient's infection. Multiple attempts were made to gather additional information including the lot number. To date, no additional information has been provided. The device was not returned for evaluation. The lot number associated with this event remains unknown; therefore an internal investigation into the device history records could not be performed. Based on the limited information, a relationship to revolve was not determined. No further actions are required, a nonconformance was not confirmed. If additional information is received, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[126243210]
Limited information was reported that a patient who underwent fat grafting with revolve developed a staph and e. Coli infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000306051-2018-00135 |
| MDR Report Key | 8041679 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-11-06 |
| Date of Report | 2018-11-06 |
| Date Mfgr Received | 2018-10-08 |
| Date Added to Maude | 2018-11-06 |
| 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 | 2018-11-06 |
| 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 | 2018-11-06 |