BACTISWAB * 12100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-06-28 for BACTISWAB * 12100 manufactured by Remel.

Event Text Entries

[20951486] As the nurse crushed the culture medium vial, a sharp object came through the plastic tube that caused the nurse to cut his finger.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1754005
MDR Report Key1754005
Date Received2010-06-28
Date of Report2010-06-28
Date of Event2010-06-12
Report Date2010-06-28
Date Reported to FDA2010-06-28
Date Added to Maude2010-07-13
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameBACTISWAB
Generic NameWOUND CULTURE SWAB & MEDIUM
Product CodeLIO
Date Received2010-06-28
Model Number*
Catalog Number12100
Lot Number862518
ID Number*
OperatorNURSE
Device AvailabilityY
Device Age1 DY
Device Sequence No1
Device Event Key0
ManufacturerREMEL
Manufacturer Address12076 SANTA FE DR. LENEXA KS 66215 US 66215


Patients

Patient NumberTreatmentOutcomeDate
10 2010-06-28

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