ELEVATING LEGREST W/ADJ CALF PAD 9153649407 T94HE

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 2015-03-19 for ELEVATING LEGREST W/ADJ CALF PAD 9153649407 T94HE manufactured by Unknown.

Event Text Entries

[5697907] It was reported that the calf pad broke off the legrest and the release lever broke on this pair of t94he legrest. Dealer thinks it was user physical damage. The patient has a cast on one foot and only had the legrest for two days.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1525712-2015-01861
MDR Report Key4615913
Report Source08
Date Received2015-03-19
Date of Report2015-03-09
Date Mfgr Received2015-03-09
Date Added to Maude2015-04-21
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 NameELEVATING LEGREST W/ADJ CALF PAD 9153649407
Generic NameFOOTREST, WHEELCHAIR
Product CodeIML
Date Received2015-03-19
Model NumberT94HE
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 2015-03-19

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