MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1998-06-04 for manufactured by .

MAUDE Entry Details

Report Number3019090-1998-00001
MDR Report Key171940
Report Source06
Date Received1998-06-04
Date of Event1998-05-08
Date Mfgr Received1998-05-22
Device Manufacturer Date1993-10-01
Date Added to Maude1998-06-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag0
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA0
Event Location0
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Product CodeEYD
Date Received1998-06-04
Device Eval'ed by MfgrY
Implant FlagN
Device Sequence No1
Device Event Key167201
Baseline Brand NameSHAMPINE (AMATECH ACCESSORY)
Baseline Generic NameSURGICAL TABLE ACCESSORY STIR-UP CLAMP
Baseline Model NoS/N 26129
Baseline Catalog No*
Baseline ID*


Patients

Patient NumberTreatmentOutcomeDate
10 1998-06-04

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