INTOUCH STABILITE OM 18 X 18 9153652435 UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-24 for INTOUCH STABILITE OM 18 X 18 9153652435 UNKNOWN manufactured by Invacare Cleveland Street.

Event Text Entries

[39337796] A follow up will be sent if the product or additional information is obtained.
Patient Sequence No: 1, Text Type: N, H10


[39337797] The backrest hardware had broke on an intouch propel back.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1219590-2016-00019
MDR Report Key5457817
Date Received2016-02-24
Date of Report2016-02-09
Date of Event2016-02-08
Date Mfgr Received2016-02-09
Date Added to Maude2016-02-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationMEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKEVIN GUYTON
Manufacturer StreetONE INVACARE WAY
Manufacturer CityELYRIA OH 44035
Manufacturer CountryUS
Manufacturer Postal44035
Manufacturer Phone8003336900
Manufacturer G1INVACARE CLEVELAND STREET
Manufacturer Street899 CLEVELAND STREET
Manufacturer CityELYRIA OH 44036
Manufacturer CountryUS
Manufacturer Postal Code44036
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameINTOUCH STABILITE OM 18 X 18 9153652435
Generic NameCUSHION, WHEELCHAIR
Product CodeIMP
Date Received2016-02-24
Model NumberUNKNOWN
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerINVACARE CLEVELAND STREET
Manufacturer Address899 CLEVELAND STREET ELYRIA OH 44036 US 44036


Patients

Patient NumberTreatmentOutcomeDate
10 2016-02-24

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