UNKNOWN REVOLVE UNK REVOLVE

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report Number1000306051-2017-00068
MDR Report Key8307741
Report SourceDISTRIBUTOR,FOREIGN,HEALTH PR
Date Received2019-02-05
Date of Report2019-02-05
Date Mfgr Received2017-08-25
Date Added to Maude2019-02-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. CHRISTOPHER BELLE
Manufacturer Street1 MILLENNIUM WAY
Manufacturer CityBRANCHBURG NJ 08876
Manufacturer CountryUS
Manufacturer Postal08876
Manufacturer Phone9089471100
Manufacturer G1LIFECELL
Manufacturer Street1 MILLENNIUM WAY
Manufacturer CityBRANCHBURG NJ 08876
Manufacturer CountryUS
Manufacturer Postal Code08876
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN REVOLVE
Generic NameSYSTEM, SUCTION, LIPOPLASTY
Product CodeMUU
Date Received2019-02-05
Catalog NumberUNK REVOLVE
Lot NumberNI
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerLIFECELL
Manufacturer Address1 MILLENNIUM WAY BRANCHBURG NJ 08876 US 08876


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-02-05

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