NI 71515

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-08-06 for NI 71515 manufactured by Medi-source, Inc..

Event Text Entries

[17487657] Slides are dirty, have a greasy film and the edges are chipped and rough. The slides are unacceptable for making blood differential smears. Poor workmanship.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW4002320
MDR Report Key183289
Date Received1998-08-06
Date of Report1998-05-27
Date Added to Maude1998-08-21
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 NameNI
Generic NameMICROSCOPE SLIDES, FROSTED
Product CodeKEW
Date Received1998-08-06
Model Number71515
Catalog NumberNI
Lot NumberNI
ID Number6640000744191
Device Availability*
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key178195
ManufacturerMEDI-SOURCE, INC.
Manufacturer Address50 GORDON DR. SYOSSET NY 11791 US


Patients

Patient NumberTreatmentOutcomeDate
10 1998-08-06

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