MAUDE Adverse Event Report: INVAMEX MECHANICAL (MANUAL) WHEELCHAIR; 890.3850

Model Number TRSX5RC

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Per (b)(6), chair was delivered with the wrong size spreader bar & the correct 18"w spreader bar needs to be sent.

• Brand Name: MECHANICAL (MANUAL) WHEELCHAIR
• Type of Device: 890.3850
• Manufacturer (Section D): INVAMEX; parque industrial manimex; reynosa 8878 0; MX 88780
• Manufacturer (Section G): INVAMEX; parque industrial manimex; reynosa 8878 0; MX 88780
• Manufacturer Contact: karen loughren ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4242269
• MDR Text Key: 17574432
• Report Number: 9616091-2014-02428
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 10/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TRSX5RC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other