SPS-1

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-27 for SPS-1 manufactured by Organ Recovery Systems, Inc..

Event Text Entries

[63285480]
Patient Sequence No: 1, Text Type: N, H10


[63285481] Patient was identified as someone affected by the potentially contaminated organ preservation solution. No harm has been noted at this point.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number6204848
MDR Report Key6204848
Date Received2016-12-27
Date of Report2016-12-22
Date of Event2016-12-21
Report Date2016-12-22
Date Reported to FDA2016-12-22
Date Reported to Mfgr2016-12-22
Date Added to Maude2016-12-27
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 NameSPS-1
Generic NameORGAN PRESERVATION FLUID
Product CodeKDL
Date Received2016-12-27
Lot NumberPBR0060392
Device Availability*
Device Age1 DY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerORGAN RECOVERY SYSTEMS, INC.
Manufacturer Address1 PIERCE PL. STE. 475W ITASCA IL 60143 US 60143


Patients

Patient NumberTreatmentOutcomeDate
10 2016-12-27

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