MAUDE Adverse Event Report: MATRIX FITNESS USA MATRIX ELLIPTICAL TRAINER; EXERCISER, NON-MEASURING

Model Number A-5XWF-06-C

Device Problem Entrapment of Device (1212)

Patient Problem Bone Fracture(s) (1870)

Event Date 08/06/2018

Event Type  malfunction  

Event Description

Reported by client on (b)(6) 2018.In the outpatient cardiac rehab dept, client was using an elliptical trainer, stating that she was pedaling forward and wanted to reverse direction.When she tried to reverse, the momentum of the forward motion of the pedal, her foot came off the pedal and was lodged between the pedal and the frame of the elliptical.Resulted in fracture of the 3rd metatarsal of the foot.Treated conservatively.

• Brand Name: MATRIX ELLIPTICAL TRAINER
• Type of Device: EXERCISER, NON-MEASURING
• Manufacturer (Section D): MATRIX FITNESS USA; cottage grove WI 53527
• MDR Report Key: 7897612
• MDR Text Key: 121564049
• Report Number: MW5080027
• Device Sequence Number: 1
• Product Code: ION
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: A-5XWF-06-C
• Device Lot Number: EP623B160600033
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 84