TRANSYSTEM STERILE TRANSPORT SWAB 900-0370

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-11 for TRANSYSTEM STERILE TRANSPORT SWAB 900-0370 manufactured by Copan Diagnostics, Inc..

Event Text Entries

[182983513] Sterile swabstick noted to be defective with one swab in package. This was in 2 different packages.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9818401
MDR Report Key9818401
Date Received2020-03-11
Date of Report2020-02-14
Date of Event2020-02-02
Report Date2020-02-14
Date Reported to FDA2020-02-14
Date Reported to Mfgr2020-03-11
Date Added to Maude2020-03-11
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTRANSYSTEM STERILE TRANSPORT SWAB
Generic NameCULTURE MEDIA, NON-PROPAGATING TRANSPORT
Product CodeJSM
Date Received2020-03-11
Model Number900-0370
Catalog Number900-0370
Lot Number191199200
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOPAN DIAGNOSTICS, INC.
Manufacturer Address26055 JEFFERSON AVENUE MURRIETA CA 92562 US 92562


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-11

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