MAUDE Adverse Event Report: INVACARE TAYLOR STREET M51P BLUE BASE W/MK5 NX SPJ+ 9153642087; WHEELCHAIR, POWERED

Model Number M51P

Device Problems Sticking (1597); Device Operates Differently Than Expected (2913)

Patient Problem Injury (2348)

Event Date 09/30/2010

Event Type  malfunction  

Manufacturer Narrative

Mdr is being submitted as a result of a retrospective complaint review.

Event Description

Consumer states she was in her kitchen going outside and the back wheel were spinning and couldn't get traction.Consumer had to get out of the chair and hop on her left leg because she recently had surgery on her right foot.Consumer states her chair was stuck on her ramp and she had to call the fire department to get her chair back in the house.Consumer states that when she was hopping in the house she hurt her hip and her shoulder.

• Brand Name: M51P BLUE BASE W/MK5 NX SPJ+ 9153642087
• Type of Device: WHEELCHAIR, POWERED
• Manufacturer (Section D): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer (Section G): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5747571
• MDR Text Key: 48158088
• Report Number: 1525712-2016-02070
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M51P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/05/2014
• 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