NSE FOOTSWITCH 5400007000

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 2015-07-02 for NSE FOOTSWITCH 5400007000 manufactured by Stryker Instruments-kalamazoo.

Event Text Entries

[16990703] It was reported during testing conducted prior to a procedure at the healthcare facility the device and an exposed wire. There was no surgical delay, medical intervention, adverse consequences or impact on the patient reported with this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001811755-2015-02395
MDR Report Key4888325
Report Source06
Date Received2015-07-02
Date of Report2015-06-09
Date of Event2015-06-09
Date Mfgr Received2015-06-09
Device Manufacturer Date2014-03-10
Date Added to Maude2015-07-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMR. CASEY METZGER
Manufacturer Street4100 EAST MILHAM AVENUE
Manufacturer CityKALAMAZOO MI 49001
Manufacturer CountryUS
Manufacturer Postal49001
Manufacturer Phone2693237700
Manufacturer G1STRYKER INSTRUMENTS-KALAMAZOO
Manufacturer Street4100 EAST MILHAM AVENUE
Manufacturer CityKALAMAZOO MI 49001
Manufacturer CountryUS
Manufacturer Postal Code49001
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNSE FOOTSWITCH
Generic NameDRIVER, WIRE, AND BONE DRILL, MANUAL
Product CodeDZJ
Date Received2015-07-02
Returned To Mfg2015-06-09
Catalog Number5400007000
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER INSTRUMENTS-KALAMAZOO
Manufacturer Address4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001


Patients

Patient NumberTreatmentOutcomeDate
10 2015-07-02

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