ACTICOAT 10X10CM CTN 12 66000791

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 2017-07-05 for ACTICOAT 10X10CM CTN 12 66000791 manufactured by Smith & Nephew Medical Ltd..

Event Text Entries

[79050698]
Patient Sequence No: 1, Text Type: N, H10


[79050699] It was reported that the dressing adhered to wound, bleeding on removal.
Patient Sequence No: 1, Text Type: D, B5


[79056239]
Patient Sequence No: 1, Text Type: N, H10


[106446045]
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number8043484-2017-00168
MDR Report Key6685797
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2017-07-05
Date of Report2017-07-24
Date of Event2017-04-05
Date Mfgr Received2017-06-12
Date Added to Maude2017-07-05
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 MARKUS POETTKER
Manufacturer StreetSCHACHENALLEE 29
Manufacturer CityAARAU 5001
Manufacturer CountrySZ
Manufacturer Postal5001
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 NameACTICOAT 10X10CM CTN 12
Generic NameDRESSING, WOUND AND BURN, OCCLUSIVE
Product CodeMGP
Date Received2017-07-05
Model Number66000791
Catalog Number66000791
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSMITH & NEPHEW MEDICAL LTD.
Manufacturer Address101 HESSLE ROAD HULL HU3 2BN UK HU3 2BN


Patients

Patient NumberTreatmentOutcomeDate
10 2017-07-05

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