VERSAJET II CONSOLE 66800039

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-04 for VERSAJET II CONSOLE 66800039 manufactured by Smith & Nephew Medical Ltd..

Event Text Entries

[177654446] It was reported that the device's white ring around the pump interface was broken and does not take pressure properly. The malfunction happened during treatment and as there was no back up available, the treatment was completed with the traditional procedure. No patient harm was reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8043484-2020-00086
MDR Report Key9665156
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-02-04
Date of Report2020-02-04
Date of Event2020-01-09
Date Mfgr Received2020-01-20
Date Added to Maude2020-02-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactDR. SARAH FREESTONE
Manufacturer Street101 HESSLE ROAD
Manufacturer CityHULL HU3 2BN
Manufacturer CountryUK
Manufacturer PostalHU3 2BN
Manufacturer Phone0447940038
Manufacturer G1SMITH & NEPHEW MEDICAL LTD.
Manufacturer Street101 HESSLE ROAD
Manufacturer CityHULL HU3 2BN
Manufacturer CountryUK
Manufacturer Postal CodeHU3 2BN
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVERSAJET II CONSOLE
Generic NameLAVAGE, JET
Product CodeFQH
Date Received2020-02-04
Catalog Number66800039
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITH & NEPHEW MEDICAL LTD.
Manufacturer Address101 HESSLE ROAD HULL UK


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-04

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