GII PS HI FLEX ISRT TR S3-4 9 71430408

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-11-29 for GII PS HI FLEX ISRT TR S3-4 9 71430408 manufactured by Smith & Nephew, Inc..

MAUDE Entry Details

Report Number1020279-2019-04205
MDR Report Key9392041
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2019-11-29
Date of Report2019-11-29
Date of Event2019-11-05
Date Mfgr Received2019-11-05
Device Manufacturer Date2011-10-06
Date Added to Maude2019-11-29
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 Street1450 BROOKS ROAD
Manufacturer CityMEMPHIS TN 38116
Manufacturer CountryUS
Manufacturer Postal38116
Manufacturer Phone0447940038
Manufacturer G1SMITH & NEPHEW, INC.
Manufacturer Street1450 BROOKS ROAD
Manufacturer CityMEMPHIS TN 38116
Manufacturer CountryUS
Manufacturer Postal Code38116
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGII PS HI FLEX ISRT TR S3-4 9
Generic NameTRAY, SURGICAL, INSTRUMENT
Product CodeFSM
Date Received2019-11-29
Returned To Mfg2019-11-23
Catalog Number71430408
Lot Number11KM03355
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITH & NEPHEW, INC.
Manufacturer Address1450 BROOKS ROAD MEMPHIS TN 38116 US 38116


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-29

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