MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-01 for * manufactured by *.
[18999697]
In initial recovery phase post-stress echo, the treadmill belt did not stop and patient fell on right arm and right lower leg. Patient declines hitting her head and stated she is fine just sore.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4972963 |
| MDR Report Key | 4972963 |
| Date Received | 2015-07-01 |
| Date of Report | 2015-07-01 |
| Date of Event | 2015-06-05 |
| Report Date | 2015-07-01 |
| Date Reported to FDA | 2015-07-01 |
| Date Reported to Mfgr | 2015-08-05 |
| Date Added to Maude | 2015-08-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | EXERCISER, POWERED |
| Product Code | BXB |
| Date Received | 2015-07-01 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PATIENT |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-01 |