9RC 9000 XT RECLINER 9153638254

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 2015-05-22 for 9RC 9000 XT RECLINER 9153638254 manufactured by Invamex.

Event Text Entries

[5815884] Customer alleged that the legrest will not lock. Customer stated that they just move all arrived and does not stay secured in place.
Patient Sequence No: 1, Text Type: D, B5


[13299640] Should additional information become available, a supplemental record will be file.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9616091-2015-01390
MDR Report Key4791739
Report Source08
Date Received2015-05-22
Date of Report2015-05-01
Date Mfgr Received2015-05-01
Date Added to Maude2015-06-19
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 G1INVAMEX
Manufacturer StreetPARQUE INDUSTRIAL MANIMEX
Manufacturer CityREYNOSA 88780
Manufacturer CountryMX
Manufacturer Postal Code88780
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name9RC 9000 XT RECLINER 9153638254
Generic NameWHEELCHAIR, MECHANICAL
Product CodeFNJ
Date Received2015-05-22
Model Number9RC
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerINVAMEX
Manufacturer AddressPARQUE INDUSTRIAL MANIMEX REYNOSA 88780 MX 88780


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2015-05-22

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