PICO SINGLE USE NPWT 10X20CM 66800951

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-31 for PICO SINGLE USE NPWT 10X20CM 66800951 manufactured by Smith & Nephew Medical Ltd..

Event Text Entries

[185914624] It was reported that the pico 7 dressing was installed on (b)(6) 2020 by the dressing nurse and on (b)(6) 2020 the patient reported that the product no longer worked, when visiting and performing the tests the pico machine did not work. No back device available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8043484-2020-00247
MDR Report Key9908566
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-02-14
Date Mfgr Received2020-03-05
Date Added to Maude2020-03-31
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 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 NamePICO SINGLE USE NPWT 10X20CM
Generic NameNEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
Product CodeOMP
Date Received2020-03-31
Catalog Number66800951
Lot Number201915
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITH & NEPHEW MEDICAL LTD.
Manufacturer Address101 HESSLE ROAD HULL HU3 2BN UK HU3 2BN


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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