UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-11-12 for UNK manufactured by Miltex Instrument Co, Inc..

MAUDE Entry Details

Report Number2431021-1998-00011
MDR Report Key196896
Report Source05,06
Date Received1998-11-12
Date of Report1998-11-11
Date of Event1998-09-23
Date Mfgr Received1998-11-10
Date Added to Maude1998-11-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location0
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Product CodeEAX
Date Received1998-11-12
Catalog NumberUNK
Lot NumberUNK
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key191300
ManufacturerMILTEX INSTRUMENT CO, INC.
Manufacturer Address6 OHIO DR - CB 5006 LAKE SUCCESS NY 110420006 US


Patients

Patient NumberTreatmentOutcomeDate
10 1998-11-12

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