MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-10-28 for TED HOSE * manufactured by Kendall.
[312647]
The patient was undergoing surgery at the time and was placed in steep trendelenburg position. The ted hose was applied by the patient prior to the positioning. It is not known what size hose the patient was given. The patient remained in the steep trendelenburg position for approximately 8. 5 hours. Upon arrival in the pacu, the patient complained of leg discomfort. The following day, it was determined that the patient had developed blisters on the dorsal area of both feet and had complaints of numbness in both legs. Approximately one week after the surgery, the patient had a neurology consult for continued numbness in the legs. One extremity had returned to 90% normal while the other was at 20 - 25% normal. The neurologist determined that the numbness was caused by compression of small nerves in the area.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 554199 |
| MDR Report Key | 554199 |
| Date Received | 2004-10-28 |
| Date of Report | 2004-10-22 |
| Date of Event | 2004-10-07 |
| Report Date | 2004-10-22 |
| Date Reported to FDA | 2004-10-28 |
| Date Added to Maude | 2004-11-12 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | TED HOSE |
| Generic Name | COMPRESSION STOCKINGS |
| Product Code | LLK |
| Date Received | 2004-10-28 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 543827 |
| Manufacturer | KENDALL |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-10-28 |