ALGISITE M 10X10CM CTN 10 66000520

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-06-24 for ALGISITE M 10X10CM CTN 10 66000520 manufactured by Smith & Nephew Medical Ltd..

MAUDE Entry Details

Report Number8043484-2019-00424
MDR Report Key8729750
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2019-06-24
Date of Report2019-09-02
Date of Event2019-05-24
Date Mfgr Received2019-07-30
Date Added to Maude2019-06-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 NameALGISITE M 10X10CM CTN 10
Generic NameDRESSING,WOUND,HYDROPHILIC
Product CodeNAC
Date Received2019-06-24
Catalog Number66000520
Lot Number1908
OperatorHEALTH PROFESSIONAL
Device Availability*
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITH & NEPHEW MEDICAL LTD.
Manufacturer Address101 HESSLE ROAD HULL UK


Patients

Patient NumberTreatmentOutcomeDate
10 2019-06-24

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