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 company representative,foreig report with the FDA on 2017-04-03 for OTTO BOCK AXTION? PROSTHETIC FOOT 1E56 1E56=N28-5-P/0 manufactured by Otto Bock Healthcare Lp.

Event Text Entries

[71578648]
Patient Sequence No: 1, Text Type: N, H10


[71578649] The end-user was using the axtion foot to walk from their garage to their house when the pyramid adapter snapped in half. No fall or injury occurred as a result of the device failure. The end-user's foot was within the warranty period and the foot was being used as intended by the manufacturer. Out of an abundance of caution, this complaint will be reported as an mdr since this confirmed device failure is known to have the potential to cause serious injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1721652-2017-00004
MDR Report Key6455524
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2017-04-03
Date of Report2017-04-03
Date of Event2017-03-08
Date Mfgr Received2017-03-28
Date Added to Maude2017-04-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. STEPHEN ANDERSON
Manufacturer Street3820 WEST GREAT LAKES DRIVE
Manufacturer CitySALT LAKE 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 Received2017-04-03
Returned To Mfg2017-03-28
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 2017-04-03

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