SECURA MOIST CLEANSE 59430900

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-15 for SECURA MOIST CLEANSE 59430900 manufactured by Smith & Nephew Medical.

Event Text Entries

[57551530] (b)(6).
Patient Sequence No: 1, Text Type: N, H10


[57551531] It was reported patient suffered burns when product was applied.
Patient Sequence No: 1, Text Type: D, B5


[68542378]
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3006760724-2016-00154
MDR Report Key6032334
Date Received2016-10-15
Date of Report2016-10-07
Date Mfgr Received2016-10-11
Date Added to Maude2016-10-15
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
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 NameSECURA MOIST CLEANSE
Generic NameDEGREASER, SKIN, SURGICAL
Product CodeKOY
Date Received2016-10-15
Model Number59430900
Catalog Number59430900
Lot Number48891
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITH & NEPHEW MEDICAL
Manufacturer Address101 HESSLE ROAD HULL HU32BN UK HU32BN


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2016-10-15

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