MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-07-26 for ALBAHEALTH * manufactured by Encompass Medical.
[21382288]
After wearing stockings patient developed stage 2 breakdown at front of ankles. Nurses applied wound dressing and oversaw more frequent removal of stockings until patient refused to wear them at all. This event is one of 11 similar incidents experienced by patients in july 2006.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 759562 |
| MDR Report Key | 759562 |
| Date Received | 2006-07-26 |
| Date of Report | 2006-07-26 |
| Date of Event | 2006-07-02 |
| Report Date | 2006-07-26 |
| Date Reported to FDA | 2006-07-26 |
| Date Added to Maude | 2006-09-14 |
| 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 | ALBAHEALTH |
| Generic Name | STOCKINGS, ANTI-EMBOLISM |
| Product Code | DWL |
| Date Received | 2006-07-26 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 747484 |
| Manufacturer | ENCOMPASS MEDICAL |
| Manufacturer Address | 16415 ADDISON ROAD; SUITE 660 ADDISON TX 75001 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-07-26 |