T-MAX EXPOSURE SHOULDER POSITIONER 7210551

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 2020-02-13 for T-MAX EXPOSURE SHOULDER POSITIONER 7210551 manufactured by Smith & Nephew, Inc..

Event Text Entries

[179449439] It was reported that, during a shoulder procedure, the t-max shoulder positioner was slowly going back. The procedure was completed using bands tied around the chair and or staff holding up the chair; nevertheless, the surgery was not delayed. The patient was not harmed. 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 Number1643264-2020-00079
MDR Report Key9706850
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2020-02-13
Date of Report2020-03-11
Date of Event2020-01-08
Date Mfgr Received2020-03-09
Date Added to Maude2020-02-13
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 Street76 S. MERIDIAN AVE.
Manufacturer CityOKLAHOMA CITY OK 731076512
Manufacturer CountryUS
Manufacturer Postal Code731076512
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameT-MAX EXPOSURE SHOULDER POSITIONER
Generic NameACCESSORIES, OPERATING-ROOM, TABLE (KIT)
Product CodeFWZ
Date Received2020-02-13
Returned To Mfg2020-01-31
Model Number7210551
Catalog Number7210551
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITH & NEPHEW, INC.
Manufacturer Address76 S. MERIDIAN AVE. OKLAHOMA CITY OK 731076512 US 731076512


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-13

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