MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-04-25 for DEVICE, UNKNOWN manufactured by .
[1854718]
My mother did in fact have other illnesses at the time of this incident, but she also had this device put in and at the time, she was doing very well, her breathing was in fact getting better and her illnesses were stable. But her breathing got seriously worse about two days after this device was put in. Then about a week after the device was in, she got put in icu and then two to three days later, she passed away. I totally believe that this device did in fact cause her death and i do intend on pursuing a lawsuit now that i know that this device has had other problems and is now being recalled.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5020401 |
| MDR Report Key | 2072694 |
| Date Received | 2011-04-25 |
| Date of Report | 2011-02-25 |
| Date of Event | 2010-10-10 |
| Date Added to Maude | 2011-05-04 |
| 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 | 0 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| 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 | DEVICE, UNKNOWN |
| Product Code | LDQ |
| Date Received | 2011-04-25 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Deathisabilit | 2011-04-25 |