MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2004-11-24 for UNK TEDS manufactured by Tyco Healthcare/kendall.
[313663]
It was reported to tyco healthcare/kendall that a customer had a problem with a pair of teds. The customer reports "the pt was undergoing surgery at the time and was placed in steep trendelenberg position. The ted hose were applied by the pt prior to the positioning. It is not known what size hose the pt was given. The pt remained in the steep trendelenberg position for approx 8. 5 hours. Upon arrival in the pacu, the pt complained of leg discomfort. The following day, it was determined that the pt developed blisters on the dorsal area of both feet and they had complaints of numbness in both legs. Approx. One week after the surgery, the pt 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 neruologist determined that the numbness was caused by compression of small nerves in the area. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017072-2004-00002 |
| MDR Report Key | 556345 |
| Report Source | 07 |
| Date Received | 2004-11-24 |
| Date of Report | 2004-11-23 |
| Date of Event | 2004-10-01 |
| Report Date | 2004-11-23 |
| Date Reported to FDA | 2004-11-23 |
| Date Reported to Mfgr | 2004-11-23 |
| Date Mfgr Received | 2004-11-23 |
| Date Added to Maude | 2004-11-26 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JILL SARAIVA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082616625 |
| Manufacturer G1 | TYCO HEALTHCARE/KENDALL |
| Manufacturer Street | 1448 BLUE RIDGE BOULEVARD |
| Manufacturer City | SENECA SC 29672 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 29672 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK TEDS |
| Generic Name | TED STOCKINGS |
| Product Code | DWL |
| Date Received | 2004-11-24 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 546014 |
| Manufacturer | TYCO HEALTHCARE/KENDALL |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-11-24 |