SVC REPL MDU HAND CNTRL PWRMX 72200616S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2019-11-29 for SVC REPL MDU HAND CNTRL PWRMX 72200616S manufactured by Smith & Nephew, Inc..

MAUDE Entry Details

Report Number1643264-2019-00846
MDR Report Key9392038
Report SourceFOREIGN,HEALTH PROFESSIONAL,O
Date Received2019-11-29
Date of Report2019-11-29
Date Mfgr Received2019-11-05
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
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 NameSVC REPL MDU HAND CNTRL PWRMX
Generic NameSAW, POWERED, AND ACCESSORIES
Product CodeHAB
Date Received2019-11-29
Catalog Number72200616S
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSMITH & NEPHEW, INC.
Manufacturer Address76 S. MERIDIAN AVE. OKLAHOMA CITY OK 731076512 US 731076512


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-29

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.