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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVAMEX TRSX5RC/WD66/28/R/U240 9153641587 WHEELCHAIR, MECHANICAL

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INVAMEX TRSX5RC/WD66/28/R/U240 9153641587 WHEELCHAIR, MECHANICAL Back to Search Results
Model Number TRSX5RC
Device Problems Frame (820); Bent (1059); Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

Should additional information become available for the patient, a supplemental record will be filed.

 
Event Description

Dealer is stating that the cross brace is bent causing the seat to not sit correctly on the frame.

 
Manufacturer Narrative

Visual inspection: the right and left seat rails were bent inward resulting in excessive sag in the seat upholstery. The right and left seat rails were misaligned with the h-blocks. Conclusions: the complaint was confirmed for the wheelchair having bent seat rails causing the seat to not align into the h-blocks.

 
Event Description

Per the returns expanded evaluation report form, it is confirmed that the seat rails are bent causing the seat to not align into the h-blocks causing the seat to sag.

 
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Brand NameTRSX5RC/WD66/28/R/U240 9153641587
Type of DeviceWHEELCHAIR, MECHANICAL
Manufacturer (Section D)
INVAMEX
parque industrial manimex
reynosa 88780
MX 88780
Manufacturer (Section G)
INVAMEX
parque industrial manimex
reynosa 88780
MX 88780
Manufacturer Contact
kevin guyton
one invacare way
elyria, OH 44035
8003336900
MDR Report Key4929186
MDR Text Key22463103
Report Number9616091-2015-01875
Device Sequence Number1
Product Code IOR
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Type of Report Initial,Followup
Report Date 07/23/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/21/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberTRSX5RC
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/23/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2015
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 07/21/2015 Patient Sequence Number: 1
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