TEST FOR SYPHILIS *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-02-12 for TEST FOR SYPHILIS * manufactured by Serologicals. Inc..

Event Text Entries

[16138054] Md was calling to alert fda that he feels that mfr has poor or deficient test procedures for syphilis. He explained that a pt of his donated plasma and they told him he was positive for syphilis. Md ran a subsequent test which was negative.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW4001768
MDR Report Key68198
Date Received1997-02-12
Date of Report1996-11-01
Date Added to Maude1997-02-13
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 NameTEST FOR SYPHILIS
Generic NameTEST SYPHILIS
Product CodeGMT
Date Received1997-02-12
Model Number*
Catalog Number*
Lot Number*
ID Number*
Device Availability*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key68201
ManufacturerSEROLOGICALS. INC.
Manufacturer Address445 BILTMORE AVE ASHEVILLE NC 28801 US


Patients

Patient NumberTreatmentOutcomeDate
10 1997-02-12

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