OTTO BOCK AXTION? PROSTHETIC FOOT 1E56 1E56=N28-5-P/0

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-05-10 for OTTO BOCK AXTION? PROSTHETIC FOOT 1E56 1E56=N28-5-P/0 manufactured by Otto Bock Healthcare Lp.

MAUDE Entry Details

Report Number1721652-2019-00003
MDR Report Key8601088
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2019-05-10
Date of Report2019-05-10
Date Mfgr Received2019-04-16
Device Manufacturer Date2014-10-29
Date Added to Maude2019-05-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. STEPHEN ANDERSON
Manufacturer Street3820 WEST GREAT LAKES DRIVE
Manufacturer CityWEST VALLEY CITY UT 84120
Manufacturer CountryUS
Manufacturer Postal84120
Manufacturer Phone8019746676
Manufacturer G1OTTO BOCK HEALTHCARE LP
Manufacturer Street3820 WEST GREAT LAKES DRIVE
Manufacturer CityWEST VALLEY CITY UT 84120
Manufacturer CountryUS
Manufacturer Postal Code84120
Single Use3
Remedial ActionRL
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOTTO BOCK AXTION? PROSTHETIC FOOT
Generic Name1E56 AXTION? PROSTHETIC FOOT
Product CodeISH
Date Received2019-05-10
Returned To Mfg2019-04-16
Model Number1E56
Catalog Number1E56=N28-5-P/0
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerOTTO BOCK HEALTHCARE LP
Manufacturer Address3820 WEST GREAT LAKES DRIVE WEST VALLEY CITY UT 84120 US 84120


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-10

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