STA COMPACT 58612

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-21 for STA COMPACT 58612 manufactured by Diagnostica Stago.

MAUDE Entry Details

Report Number2245451-2020-00002
MDR Report Key9610237
Date Received2020-01-21
Date of Report2019-12-03
Date of Event2019-12-02
Date Facility Aware2019-12-03
Report Date2020-01-20
Date Reported to FDA2020-01-20
Date Reported to Mfgr2020-01-20
Date Added to Maude2020-01-21
Event Key0
Report Source CodeDistributor 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 NameSTA COMPACT
Generic NameIVD COAGULATION DEVICE / INSTRUMENT, PRODUCT CODE: JPA
Product CodeJPA
Date Received2020-01-21
Model Number58612
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age15 YR
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerDIAGNOSTICA STAGO
Manufacturer Address3 ALL?E TH?R?SA ASNI?RES-SUR-SEINE, 92600 FR 92600


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-01-21

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