MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-10-16 for MXD manufactured by Mytrex, Inc..
[16058102]
Subscriber fell in her home and her health alert personal emergency response button did not work when she pressed it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5032324 |
| MDR Report Key | 3421089 |
| Date Received | 2013-10-16 |
| Date of Report | 2013-10-15 |
| Date of Event | 2013-10-07 |
| Date Added to Maude | 2013-10-22 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | MEDICAL ALERT UNIT |
| Product Code | ILQ |
| Date Received | 2013-10-16 |
| Model Number | MXD |
| ID Number | 1603578 |
| Operator | LAY USER/PATIENT |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MYTREX, INC. |
| Manufacturer Address | SOUTH JORDAN UT 85095 US 85095 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-10-16 |