PRIME TC SWING-AWAY MODEL 1460000000

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 2020-01-27 for PRIME TC SWING-AWAY MODEL 1460000000 manufactured by Stryker Medical-kalamazoo.

Event Text Entries

[176500776] This mdr is part of the fda voluntary malfunction summary reporting program. The device was evaluated in the field and the issue was confirmed; there was a broken/damaged component. The device was repaired and returned. There was no remedial action taken. This device is not labeled for single use.
Patient Sequence No: 1, Text Type: N, H10


[176500777] This report summarizes 1 malfunction event, where it was reported there were accessible sharp metal edges. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001831750-2020-00032
MDR Report Key9634049
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-01-27
Date of Report2020-01-27
Date of Event2020-01-01
Date Mfgr Received2020-01-01
Date Added to Maude2020-01-27
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. KRISTEN CANTER
Manufacturer Street3800 EAST CENTRE AVENUE
Manufacturer CityPORTAGE MI 49002
Manufacturer CountryUS
Manufacturer Postal49002
Manufacturer Phone2693292100
Manufacturer G1STRYKER MEDICAL-KALAMAZOO
Manufacturer Street3800 EAST CENTRE AVENUE
Manufacturer CityPORTAGE MI 49002
Manufacturer CountryUS
Manufacturer Postal Code49002
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePRIME TC SWING-AWAY MODEL
Generic NameCHAIR, ADJUSTABLE, MECHANICAL
Product CodeINN
Date Received2020-01-27
Catalog Number1460000000
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER MEDICAL-KALAMAZOO
Manufacturer Address3800 EAST CENTRE AVENUE PORTAGE MI 49002 US 49002


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-27

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