ID-MTS READER SA MTS9945

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-03-10 for ID-MTS READER SA MTS9945 manufactured by Micro Typing Systems, Inc..

Event Text Entries

[319366] Lid on reader sa could slam shut if hinge assembly is broken. No death or serious injury was associated with this incident.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1058138-2004-00007
MDR Report Key533770
Report Source05
Date Received2004-03-10
Date of Report2004-03-09
Date of Event2004-03-01
Date Mfgr Received2004-03-01
Device Manufacturer Date2001-07-01
Date Added to Maude2004-07-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactCATHERINE MCMULLEN, SITE DIRECTOR
Manufacturer Street1295 SW 29TH AVE.
Manufacturer CityPOMPANO BEACH FL 33069
Manufacturer CountryUS
Manufacturer Postal33069
Manufacturer Phone9546239537
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameID-MTS READER SA
Generic NameBLOOD GROUPING CENTRIFUGE AND READER
Product CodeKSO
Date Received2004-03-10
Model NumberMTS9945
Catalog NumberMTS READER SA
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key523045
ManufacturerMICRO TYPING SYSTEMS, INC.
Manufacturer Address1295 SW 29TH AVE POMPANO BEACH FL 33069 US
Baseline Brand NameMTS READER SA
Baseline Generic NameBLOOD GROUPING CENTRIFUGE AND READER
Baseline Model NoMTS9945
Baseline Catalog NoMTS9945
Baseline IDNA
Baseline Device FamilyNA
Baseline Shelf Life ContainedN
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK000018
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
10 2004-03-10

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