RENASYS TCH DEVICE&POWER SPLY 66801280

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 2019-11-29 for RENASYS TCH DEVICE&POWER SPLY 66801280 manufactured by Smith & Nephew Medical Ltd..

MAUDE Entry Details

Report Number8043484-2019-00872
MDR Report Key9391675
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-11-29
Date of Report2019-11-29
Date of Event2019-11-05
Date Mfgr Received2019-11-05
Date Added to Maude2019-11-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactDRA SARAH FREESTONE
Manufacturer Street101 HESSLE ROAD HULL
Manufacturer CountryUK
Manufacturer Phone4407940038
Manufacturer G1SMITH & NEPHEW MEDICAL LTD.
Manufacturer Street101 HESSLE ROAD
Manufacturer CityHULL
Manufacturer CountryUK
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRENASYS TCH DEVICE&POWER SPLY
Generic NameNEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
Product CodeOMP
Date Received2019-11-29
Catalog Number66801280
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 2019-11-29

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