INTRASITE GEL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2016-10-25 for INTRASITE GEL manufactured by Smith & Nephew Medical Ltd..

Event Text Entries

[58294717]
Patient Sequence No: 1, Text Type: N, H10


[58294718] It was reported that a patient using intrasite gel suffered from an eczematous eruption on the site of application.
Patient Sequence No: 1, Text Type: D, B5


[106171917]
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number8043484-2016-00152
MDR Report Key6053616
Report SourceFOREIGN,LITERATURE
Date Received2016-10-25
Date of Report2017-08-01
Date of Event2016-10-06
Date Mfgr Received2016-10-06
Date Added to Maude2016-10-25
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 ContactMRS CLAUDIA ODOY
Manufacturer StreetSCHACHENALLEE 29
Manufacturer CityAARAU 5001
Manufacturer CountrySZ
Manufacturer Postal5001
Manufacturer Phone0628320660
Manufacturer G1SMITH & NEPHEW MEDICAL SUZHOU LIMITED
Manufacturer StreetNO.12 WUXIANG ROAD. COMPREHENSIVE FREE ZONE,WEST Z
Manufacturer CitySUZHOU 215021
Manufacturer CountryCH
Manufacturer Postal Code215021
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINTRASITE GEL
Generic NameBANDAGE, LIQUID
Product CodeKMF
Date Received2016-10-25
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITH & NEPHEW MEDICAL LTD.
Manufacturer Address101 HESSLE ROAD HULL HU32BN UK HU32BN


Patients

Patient NumberTreatmentOutcomeDate
10 2016-10-25

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