REAMER, LOW PROFILE AR-1410LP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-29 for REAMER, LOW PROFILE AR-1410LP manufactured by Arthrex, Inc..

MAUDE Entry Details

Report Number9391793
MDR Report Key9391793
Date Received2019-11-29
Date of Report2019-11-20
Date of Event2019-11-19
Report Date2019-11-20
Date Reported to FDA2019-11-20
Date Reported to Mfgr2019-11-29
Date Added to Maude2019-11-29
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameREAMER, LOW PROFILE
Generic NameORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Product CodeLXH
Date Received2019-11-29
Model NumberAR-1410LP
Catalog NumberAR-1410LP
Lot Number10387204
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerARTHREX, INC.
Manufacturer Address1370 CREEKSIDE BLVD NAPLES FL 34108 US 34108


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-29

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