SICKLEDEX 773500

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-11-29 for SICKLEDEX 773500 manufactured by Ortho-clinical Diagnostics, Inc..

Event Text Entries

[407333] Customer reported that a negative reaction was observed with a hemoglobin s patient. No death or serious injury was associated with the incident.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2250051-2005-50561
MDR Report Key650084
Date Received2005-11-29
Date of Report2005-11-28
Date of Event2005-10-31
Date Added to Maude2005-12-08
Event Key0
Report Source CodeDistributor 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 Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSICKLEDEX
Generic NameNA
Product CodeJCM
Date Received2005-11-29
Model NumberNA
Catalog Number773500
Lot Number5172
ID NumberNA
Device Expiration Date2006-06-27
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key639561
ManufacturerORTHO-CLINICAL DIAGNOSTICS, INC.
Manufacturer Address1001 US HWY 202 RARITAN NJ 08869 US
Baseline Brand NameSICKLEDEX
Baseline Generic NameNA
Baseline Model NoNA
Baseline Catalog No773500
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2005-11-29

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