MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2000-09-21 for ACTIVX NA-PREPRODUCTION * manufactured by Adorno Rogers Technology.
[170656]
In mid-july 2000, the pt was provided with an activx wheelchair and a pair of preproduction elevating leg rests (elr) for evaluation of ease-of-use and functionality. This pt was a bilateral amputee and required transfer aids to move to and from the wheelchair. On august 9, 2000, an adorno rogers technology (a/at) employee was contacted by the case mgr and notified that the pt died in post operation due to heart failure and the chair would be returned. Upon arriving to retrieve the chair, the a/rt rep noted that one of the calf pad bracket pins had broken. The therapist indicated that the pt had fallen and sustained an injury, requiring the surgery from which pt did not recover. She also indicated that pt might have fallen while mis-using the elr as a transfer device to move from wheelchair to the bed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1650799-2000-00001 |
| MDR Report Key | 297494 |
| Report Source | 05,06 |
| Date Received | 2000-09-21 |
| Date of Report | 2000-09-20 |
| Date of Event | 2000-08-09 |
| Device Manufacturer Date | 2000-07-01 |
| Date Added to Maude | 2000-09-27 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DANNY WHITE |
| Manufacturer Street | 1700 S LAMAR STE 240 |
| Manufacturer City | AUSTIN TX 78734 |
| Manufacturer Country | US |
| Manufacturer Postal | 78734 |
| Manufacturer Phone | 5124424229 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACTIVX |
| Generic Name | ELEVATING LEG REST |
| Product Code | KNO |
| Date Received | 2000-09-21 |
| Model Number | NA-PREPRODUCTION |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 287953 |
| Manufacturer | ADORNO ROGERS TECHNOLOGY |
| Manufacturer Address | 101 WEST 6TH ST., SUITE 400 AUSTIN TX 78701 US |
| Baseline Brand Name | ACTIVX |
| Baseline Generic Name | ELEVATING LEG REST |
| Baseline Model No | NA-PREPRODUCTIO |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-09-21 |