TPS UNIDIRECTIONAL FOOTSWITCH 5100007000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-28 for TPS UNIDIRECTIONAL FOOTSWITCH 5100007000 manufactured by Stryker Instruments-kalamazoo.

Event Text Entries

[177795911] This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program. Reported events: 1 event was reported for this quarter. Product return status: 1 device investigation type has not yet been determined. Additional information: 1 device was not labeled for single-use. 1 device was not reprocessed or reused.
Patient Sequence No: 1, Text Type: N, H10


[177795912] This report summarizes 1 malfunction event in which the device ran without user activation. 1 event had no patient involvement; no patient impact.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001811755-2020-00232
MDR Report Key9636719
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-01-28
Date of Report2020-01-28
Date of Event2019-12-31
Date Mfgr Received2019-12-31
Date Added to Maude2020-01-28
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. ZACH BAKER
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 NameTPS UNIDIRECTIONAL FOOTSWITCH
Generic NameUNIT, OPERATIVE DENTAL
Product CodeEIA
Date Received2020-01-28
Model Number5100007000
Catalog Number5100007000
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER INSTRUMENTS-KALAMAZOO
Manufacturer Address4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-28

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