HEMOCCULT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-30 for HEMOCCULT manufactured by Beckman Coulter, Inc..

Event Text Entries

[125468873] Stool for occult blood sent; lab called and said there was something wrong with the specimen cards. They are light blue in color to start before the testing was done, and blue is a positive test.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8018794
MDR Report Key8018794
Date Received2018-10-30
Date of Report2018-09-26
Date of Event2018-08-15
Report Date2018-10-12
Date Reported to FDA2018-10-12
Date Reported to Mfgr2018-10-30
Date Added to Maude2018-10-30
Event Key0
Report Source CodeUser Facility 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 Report3

Device Details

Brand NameHEMOCCULT
Generic NameREAGENT, OCCULT BLOOD
Product CodeKHE
Date Received2018-10-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerBECKMAN COULTER, INC.
Manufacturer Address250 S. KRAEMER BLVD BREA CA 92821 US 92821


Patients

Patient NumberTreatmentOutcomeDate
10 2018-10-30

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