MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-20 for MATRIX ELLIPTICAL TRAINER A-5XWF-06-C manufactured by Matrix Fitness Usa.
[121564049]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080027 |
| MDR Report Key | 7897612 |
| Date Received | 2018-09-20 |
| Date of Report | 2018-09-19 |
| Date of Event | 2018-08-06 |
| Date Added to Maude | 2018-09-21 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MATRIX ELLIPTICAL TRAINER |
| Generic Name | EXERCISER, NON-MEASURING |
| Product Code | ION |
| Date Received | 2018-09-20 |
| Model Number | A-5XWF-06-C |
| Lot Number | EP623B160600033 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MATRIX FITNESS USA |
| Manufacturer Address | COTTAGE GROVE WI 53527 US 53527 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-20 |