TREATMENT RECLINER 3500000710

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-10 for TREATMENT RECLINER 3500000710 manufactured by Stryker Medical-kalamazoo.

Event Text Entries

[69961224] Repair parts were sent to the customer and they made the repairs themselves.
Patient Sequence No: 1, Text Type: N, H10


[69961225] It was reported that that the cross bar in the back of the chair was split causing the chair to not support patient weight. No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001831750-2017-00065
MDR Report Key6397090
Date Received2017-03-10
Date of Report2017-03-10
Date of Event2017-02-13
Date Mfgr Received2017-02-13
Device Manufacturer Date2011-03-22
Date Added to Maude2017-03-10
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. CHANDA BURGHARD
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 Report0

Device Details

Brand NameTREATMENT RECLINER
Generic NameCHAIR, EXAMINATION AND TREATMENT
Product CodeFRK
Date Received2017-03-10
Catalog Number3500000710
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER MEDICAL-KALAMAZOO
Manufacturer Address3800 EAST CENTRE AVENUE PORTAGE MI 49002 US 49002


Patients

Patient NumberTreatmentOutcomeDate
10 2017-03-10

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