MAUDE Adverse Event Report: INVACARE CANADA KIRKLAND TRSX5/WD08/AD/28/34P/U240/1255/U2222/AHDRM/9691B/GVT93HC/G1360/BH16 9153649403; WHEELCHAIR, MECHANICAL

Model Number MYONADLT

Device Problems Device Tipped Over (2589); Device Dislodged or Dislocated (2923)

Patient Problems Fall (1848); Injury (2348)

Event Type  malfunction  

Manufacturer Narrative

Should additional information become available a supplemental record will be filed.

Event Description

The dealer states the consumer was in the chair and the top bolt came out of the head tube plate.The dealer states this caused the fork to pivot which caused the chair to tip forward and threw the consumer out of the chair.The dealer states he was able to put the bolt back in and tighten it so nothing had to be replaced.The dealer states he also tightened the other side because it had also loosened up.The consumer states the fall caused a minor cut 3 inches above the back of the ankle.No stitches or medical intervention was required.

• Brand Name: TRSX5/WD08/AD/28/34P/U240/1255/U2222/AHDRM/9691B/GVT93HC/G1360/BH16 9153649403
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): INVACARE CANADA KIRKLAND; 16769 hymus blvd.; kirkland qc H9H 3 L4; CA H9H 3L4
• Manufacturer (Section G): INVACARE CANADA KIRKLAND; 16769 hymus blvd.; kirkland qc H9H 3 L4; CA H9H 3L4
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5200901
• MDR Text Key: 30622910
• Report Number: 3002416487-2015-00112
• 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: 10/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MYONADLT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/15/2015
• Initial Date FDA Received: 11/04/2015
• 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