MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,user facilit report with the FDA on 2018-05-11 for TMX425 FVMILL-AAA-EABAB manufactured by Mortara Instrument, Inc..
[107992555]
There was no allegation of malfunction. The patient was on the treadmill and when the stage changed at 4 min, the patient fell on her left side. She sustained injuries to her left shoulder and left knee which have left her with loss of motion and pain in the left shoulder and discomfort in the left knee. The patient was seriously injured as defined by fda due to permanent injury. This treadmill is intended to be used during stress testing. It is equipped with an emergency stop button for the patient as well as can be stopped by the clinician using the stress system that is controlling it. Furthermore, standard of care dictates that exercise stress tests on treadmills are closely supervised.
Patient Sequence No: 1, Text Type: N, H10
[107992557]
Mortara instrument received a report from the account stating a patient fell during an exercise stress test from the treadmill. The treadmill was located at the account. The complaint was filed in our complaint handling system as complaint # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183461-2018-00001 |
| MDR Report Key | 7506529 |
| Report Source | CONSUMER,FOREIGN,USER FACILIT |
| Date Received | 2018-05-11 |
| Date of Report | 2018-04-11 |
| Date of Event | 2016-07-29 |
| Date Mfgr Received | 2018-04-11 |
| Date Added to Maude | 2018-05-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 3017 FULL VISION DR |
| Manufacturer City | NEWTON KS 67114 |
| Manufacturer Country | US |
| Manufacturer Postal | 67114 |
| Manufacturer Phone | 3162833344 |
| Manufacturer G1 | MORTARA INSTRUMENT, INC. |
| Manufacturer City | WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TMX425 |
| Generic Name | TREADMILL |
| Product Code | IOL |
| Date Received | 2018-05-11 |
| Model Number | FVMILL-AAA-EABAB |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MORTARA INSTRUMENT, INC. |
| Manufacturer Address | 7865 N. 86TH STREET MILWAUKEE WI 53224 US 53224 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2018-05-11 |