MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-14 for TRACER EX2 TREX26RP manufactured by Invacare.
[117440193]
The pt was sitting in her wheelchair, slid out onto the floor. The pt complained of pain in her right leg and was noted with decreased mobility of right leg. An x-ray was ordered that showed a right hip fracture. The pt's husband opted for comfort care, pain mgmt and not aggressive treatment. The pt remained in hospice with comfort measures and died (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7788234 |
| MDR Report Key | 7788234 |
| Date Received | 2018-08-14 |
| Date of Report | 2018-08-14 |
| Date of Event | 2018-08-07 |
| Date Facility Aware | 2018-08-07 |
| Report Date | 2018-08-14 |
| Date Reported to FDA | 2018-08-14 |
| Date Reported to Mfgr | 2018-08-14 |
| Date Added to Maude | 2018-08-16 |
| 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 | 3 |
| 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 | TRACER EX2 |
| Generic Name | STANDARD 16" WHEELCHAIR |
| Product Code | INB |
| Date Received | 2018-08-14 |
| Model Number | TREX26RP |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVACARE |
| Manufacturer Address | ELYRIA OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Required No Informationntervention | 2018-08-14 |