CULTURETTE * 01-826C

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-10-09 for CULTURETTE * 01-826C manufactured by Becton Dickinson And Co.

Event Text Entries

[256181] With current stock hosp has observed false positive patient results for the group a streptococcus direct test.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report NumberMW1026405
MDR Report Key421922
Date Received2002-10-09
Date of Report2002-10-09
Date Added to Maude2002-10-17
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameCULTURETTE
Generic NameBACTERIOLOGICAL SPECIMEN COLLECITON AND TRANSPORTATION SYSTE
Product CodeJSC
Date Received2002-10-09
Model Number*
Catalog Number01-826C
Lot Number12801
ID Number*
Device Expiration Date2003-07-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key410974
ManufacturerBECTON DICKINSON AND CO
Manufacturer Address* SPARKS MD 21152 US

Device Sequence Number: 2

Brand NameCULTURETTE
Generic NameBACTERIOLOGICAL SPECIMEN COLLECTION AND TRANSPORTATION SYSTE
Product CodeJSC
Date Received2002-10-09
Model Number*
Catalog Number01-826C
Lot Number12102
ID Number*
Device Expiration Date2003-07-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age*
Implant FlagN
Date Removed*
Device Sequence No2
Device Event Key410982
ManufacturerBECTON DICKINSON AND CO
Manufacturer Address* SPARKS MD 21152 US

Patients

Patient NumberTreatmentOutcomeDate
10 2002-10-09
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