KIT STABILIZATION SHOULDER (12) 7210573

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 2020-03-24 for KIT STABILIZATION SHOULDER (12) 7210573 manufactured by Smith & Nephew, Inc..

Event Text Entries

[187755934] It was reported that, during a procedure, the surgeon used the shoulder stabilization kit but the bandage was damaged and could not be used. The procedure was completed with a device from a competitor brand. No delay or patient injury was reported. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003604053-2020-00017
MDR Report Key9873296
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-24
Date of Report2020-03-24
Date of Event2020-02-27
Date Mfgr Received2020-02-28
Date Added to Maude2020-03-24
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 ContactHOLLY TOPPING
Manufacturer Street7000 WEST WILLIAM CANNON DRIVE
Manufacturer CityAUSTIN TX 78735
Manufacturer CountryUS
Manufacturer Postal78735
Manufacturer Phone5123913905
Manufacturer G1SMITH & NEPHEW, INC.
Manufacturer Street150 MINUTEMAN ROAD
Manufacturer CityANDOVER MA 01810
Manufacturer CountryUS
Manufacturer Postal Code01810
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameKIT STABILIZATION SHOULDER (12)
Generic NameACCESSORIES, OPERATING-ROOM, TABLE (KIT)
Product CodeFWZ
Date Received2020-03-24
Model Number7210573
Catalog Number7210573
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSMITH & NEPHEW, INC.
Manufacturer Address150 MINUTEMAN ROAD ANDOVER MA 01810 US 01810


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-24

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