MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 1999-04-09 for manufactured by .

MAUDE Entry Details

Report Number9610614-1999-00002
MDR Report Key218304
Report Source08
Date Received1999-04-09
Date of Event1999-03-18
Date Mfgr Received1999-03-30
Date Added to Maude1999-04-13
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
Remedial ActionRC
Previous Use Code3
Event Type3
Type of Report3

Device Details

Product CodeMNJ
Date Received1999-04-09
Device Eval'ed by MfgrY
Implant FlagN
Device Sequence No1
Device Event Key211716
Baseline Brand NamePRESSURE REDUCTION VALVE
Baseline Generic NamePRESSURE REDUCTION VALVE
Baseline Model No20132-065
Baseline Catalog No20132-065
Baseline ID*


Patients

Patient NumberTreatmentOutcomeDate
10 1999-04-09

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