SKYTRON 6500 ELITE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-27 for SKYTRON 6500 ELITE manufactured by Skytron Llc.

MAUDE Entry Details

Report Number9128337
MDR Report Key9128337
Date Received2019-09-27
Date of Report2019-09-19
Date of Event2019-09-13
Report Date2019-09-19
Date Reported to FDA2019-09-19
Date Reported to Mfgr2019-09-27
Date Added to Maude2019-09-27
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSKYTRON
Generic NameTABLE, OPERATING-ROOM, AC-POWERED
Product CodeFQO
Date Received2019-09-27
Model Number6500 ELITE
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSKYTRON LLC
Manufacturer Address5085 CORPORATE EXCHANGE BLVD SE GRAND RAPIDS MI 49512 US 49512


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-27

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