PLATINUM CODE 1X18 ORANGE SMOOTH TOURNIQUET 48NLO-FP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-13 for PLATINUM CODE 1X18 ORANGE SMOOTH TOURNIQUET 48NLO-FP manufactured by Platinum Code / Ipc Inc..

MAUDE Entry Details

Report NumberMW5089002
MDR Report Key8893073
Date Received2019-08-13
Date of Report2019-08-12
Date of Event2019-08-08
Date Added to Maude2019-08-14
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NamePLATINUM CODE 1X18 ORANGE SMOOTH TOURNIQUET
Generic NameTOURNIQUET, NONPNEUMATIC
Product CodeGAX
Date Received2019-08-13
Model Number48NLO-FP
Lot Number15772
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerPLATINUM CODE / IPC INC.
Manufacturer AddressLAKEVILLE MN 55044 US 55044


Patients

Patient NumberTreatmentOutcomeDate
10 2019-08-13

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.