ROLLATOR 9153651315 UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2015-04-23 for ROLLATOR 9153651315 UNKNOWN manufactured by Unknown.

Event Text Entries

[20720758] Provider states the brake handle is broken on the rollator.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1525712-2015-02682
MDR Report Key4722019
Report Source08
Date Received2015-04-23
Date of Report2015-04-14
Date Mfgr Received2015-04-14
Date Added to Maude2015-05-21
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 FDA0
Event Location0
Manufacturer ContactKEVIN GUYTON
Manufacturer StreetONE INVACARE WAY
Manufacturer CityELYRIA OH 44035
Manufacturer CountryUS
Manufacturer Postal44035
Manufacturer Phone8003336900
Manufacturer G1UNKNOWN
Manufacturer CityOH
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameROLLATOR 9153651315
Generic NameWALKER, MECHANICAL
Product CodeKIC
Date Received2015-04-23
Model NumberUNKNOWN
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerUNKNOWN
Manufacturer AddressOH US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2015-04-23

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