QUICKVUE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-07-06 for QUICKVUE * manufactured by *.

Event Text Entries

[228458] A series of pts presented to office with pharyngitis. Dr performed simultaneous quikstrep (with quikvue) and standard throat cultures. In all cases the quickvue came back negative, but cultures grew out heavy growth of group a strep.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1022339
MDR Report Key341111
Date Received2001-07-06
Date of Report2001-07-05
Date Added to Maude2001-07-12
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameQUICKVUE
Generic NameQUICK STREPANTIGEN DEVICE
Product CodeGTY
Date Received2001-07-06
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device Availability*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key330438
Manufacturer*
Manufacturer Address* * *


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2001-07-06

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