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 2001-03-08 for manufactured by .

MAUDE Entry Details

Report Number1526350-2001-00005
MDR Report Key320039
Report Source05,06
Date Received2001-03-08
Date of Event2000-12-21
Date Mfgr Received2000-12-27
Device Manufacturer Date2000-08-01
Date Added to Maude2001-03-14
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
Manufacturer ContactPAUL OSORIO
Manufacturer Street200 W. OHIO AVE
Manufacturer CityDOVER OH 44622
Manufacturer CountryUS
Manufacturer Postal44622
Manufacturer Phone3303438801
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Product CodeDRP
Date Received2001-03-08
Device Eval'ed by MfgrY
Implant FlagN
Device Sequence No1
Device Event Key309562
Baseline Brand NameZIMMER ATS 2000
Baseline Generic NameAUTOMATIC TOURNIQUET SYSTEM
Baseline Model No*
Baseline Catalog NoREF. 60-2000-101
Baseline ID*


Patients

Patient NumberTreatmentOutcomeDate
10 2001-03-08

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