REGARD 800746

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-23 for REGARD 800746 manufactured by Resource Optimization And Innovation Llc.

Event Text Entries

[109274495] Found on a safety cap of a needle, within a sterile pack, was a particle dark in color.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5077419
MDR Report Key7540361
Date Received2018-05-23
Date of Report2018-05-21
Date of Event2018-05-21
Date Added to Maude2018-05-24
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameREGARD
Generic NameHT0951 - CORONARY FEMORAL
Product CodeOES
Date Received2018-05-23
Returned To Mfg2018-05-21
Catalog Number800746
Lot Number050678
Device Expiration Date2019-12-07
Device AvailabilityR
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerRESOURCE OPTIMIZATION AND INNOVATION LLC
Manufacturer AddressPO BOX 505160 ST. LOUIS MO 631505160 US 631505160


Patients

Patient NumberTreatmentOutcomeDate
10 2018-05-23

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