MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2019-02-05 for UNKNOWN REVOLVE UNK REVOLVE manufactured by Lifecell.
[135186238]
(b)(6). The device was not returned for evaluation. The lot associated with this complaint remains unknown; therefore a review of the device history records could not be performed. Lifecell reports this event in an abundance of caution as serious injury which may be treated with either medical or surgical intervention. Lifecell has made multiple attempts to obtain patient and procedure specific information, including the associated lot number. To date, no additional information has been provided. Aside from the initial information reported, the surgeon does not want to provide anything further. Based on the limited information reported with without the associated lot number, a relationship between the infection and the revolve could not be determined. If additional information is received, a follow up report will be submitted. As per the ifu, potential adverse effects associated with revolve system include infection.
Patient Sequence No: 1, Text Type: N, H10
[135186239]
Limited information was reported that the surgeon trialed a revolve device on a female patient in 2016. The patient subsequently developed a post-operative infection. Procedure dates, onset date of infection, course of treatment, type of infection and lot number information was not reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000306051-2017-00068 |
| MDR Report Key | 8307741 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2019-02-05 |
| Date of Report | 2019-02-05 |
| Date Mfgr Received | 2017-08-25 |
| Date Added to Maude | 2019-02-05 |
| 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 | 2019-02-05 |
| 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 | 2019-02-05 |