ORTHO REAGENT RED BLOOD CELLS 0.8% SURGISCREEN 6902316

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-07 for ORTHO REAGENT RED BLOOD CELLS 0.8% SURGISCREEN 6902316 manufactured by Ortho Clinical Diagnostics.

MAUDE Entry Details

Report Number2250051-2020-00001
MDR Report Key9560029
Report SourceHEALTH PROFESSIONAL
Date Received2020-01-07
Date of Report2020-01-07
Date of Event2019-12-12
Date Mfgr Received2019-12-13
Device Manufacturer Date2019-10-29
Date Added to Maude2020-01-07
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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
Manufacturer ContactMR. JAMES A STEVENS
Manufacturer Street1001 ROUTE 202
Manufacturer CityRARITAN NJ 08869
Manufacturer CountryUS
Manufacturer Postal08869
Manufacturer Phone9082188223
Manufacturer G1ORTHO CLINICAL DIAGNOSTICS
Manufacturer Street1001 ROUTE 202
Manufacturer CityRARITAN NJ 08869
Manufacturer CountryUS
Manufacturer Postal Code08869
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameORTHO REAGENT RED BLOOD CELLS 0.8% SURGISCREEN
Generic NameREAGENT RED BLOOD CELLS
Product CodeKSZ
Date Received2020-01-07
Catalog Number6902316
Lot NumberVSS144
Device Expiration Date2019-12-31
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerORTHO CLINICAL DIAGNOSTICS
Manufacturer Address1001 ROUTE 202 RARITAN NJ 08869 US 08869


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-07

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