PICO 7 15CM X 15CM 66802005

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 2020-03-30 for PICO 7 15CM X 15CM 66802005 manufactured by Smith & Nephew Medical Ltd..

Event Text Entries

[185902242] It was reported that after orthopedic surgery in the trochanter, while the patient was using the pico dressing, it did not absorb the exudate which was accumulated in the surrounding skin, causing skin irritation and dermatitis. The dressing was applied for 5 days, and it had no visible sign of exudate in the absorbent layer. The customer replaced the pico and maintained the treatment. The skin was cleaned and protected with secura. No medical intervention needed, no patient harm.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8043484-2020-00239
MDR Report Key9901631
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2020-03-04
Date Mfgr Received2020-03-04
Date Added to Maude2020-03-30
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 7 15CM X 15CM
Generic NameNEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
Product CodeOMP
Date Received2020-03-30
Catalog Number66802005
Lot NumberUNKNOWN
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 2020-03-30

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