INCSTARCORP CMV UVE KIT 24300

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1996-09-12 for INCSTARCORP CMV UVE KIT 24300 manufactured by Inc Star Corp..

Event Text Entries

[28504] Decreased staining intensity of positive control and samples using cmv-vue kit. Kit contains instructions and materials for the qualitative detection of early structural protein of cmv.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2182595-1996-09001
MDR Report Key41027
Report Source06
Date Received1996-09-12
Date of Report1996-09-06
Date of Event1996-09-06
Date Mfgr Received1996-09-06
Device Manufacturer Date1996-05-01
Date Added to Maude1996-10-08
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Remedial ActionRL
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINCSTARCORP CMV UVE KIT
Generic NameIN VITRO DIAGNOSTIC
Product CodeLIN
Date Received1996-09-12
Model NumberNA
Catalog Number24300
Lot Number315676, 315676A
ID NumberNA
Device Expiration Date1997-05-07
OperatorOTHER
Device AvailabilityY
Device Age*
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key42112
ManufacturerINC STAR CORP.
Manufacturer Address1990 INDUSTRIAL BLVD STILLWATER MN 55082 US
Baseline Brand NameINSTAR CORP CMV-VUE
Baseline Generic NameCMV-VUE DIAGNOSTIC KIT
Baseline Model NoNA
Baseline Catalog No24300
Baseline IDNA
Baseline Device FamilyIN VITRO DIAGNOSTIC
Baseline Shelf Life ContainedY
Baseline Shelf Life [Months]12
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK921616
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
10 1996-09-12

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