MAUDE Adverse Event Report: UNKNOWN DEMO 1 REVEAL WHEELCHAIR SHOW CHAIR; WHEELCHAIR, MECHANICAL

Model Number SELFCARE

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Device Markings/Labelling Problem (2911)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

End user states the left rear wheel keeps falling off.End user is second owner.Customer reports having unit for 7 years and is unable to identify model.Orange label (b)(4) date 11/03.Invacare logo on backrest.

• Brand Name: DEMO 1 REVEAL WHEELCHAIR SHOW CHAIR
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): UNKNOWN; OH
• Manufacturer (Section G): UNKNOWN; OH
• Manufacturer Contact: karen loughren ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 4333575
• MDR Text Key: 16629292
• Report Number: 1525712-2014-07943
• 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: Patient
• Type of Report: Initial
• Report Date: 10/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SELFCARE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/27/2014
• 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