STREP SELECT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-05-17 for STREP SELECT manufactured by Becton Dickinson Microbiology Systems.

Event Text Entries

[13672] The first week the reporter started using this product, she noticed an unusual number were exhibiting no growth. She replated many of the culturettes the next day on a routine screening plate and found a lot were positive for group a strep. In one case, a 15-year-old was not initially treated and ended up being hospitalized. When he was replated heavy growth was found. Rptr feels this product is not as good as the routine blood auger. She has reported her concerns to the mfr and to the state health department.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1005957
MDR Report Key21845
Date Received1995-05-17
Date of Report1995-04-20
Date of Event1995-04-11
Date Added to Maude1995-05-18
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationMEDICAL TECHNOLOGIST
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSTREP SELECT
Generic NameAUGER PLATE
Product CodeGTY
Date Received1995-05-17
Lot Number21779, 21780
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key21906
ManufacturerBECTON DICKINSON MICROBIOLOGY SYSTEMS
Manufacturer AddressCOCKEYSVILLE MD 21030 US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 1995-05-17

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