MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-05-01 for 3071LF TED STKG NYL T/L SS manufactured by Tyco Healthcare/kendall.
[629458]
It was reported to tyco healthcare/kendall that a customer had an incident with a pair of ted stockings. The customer stated that there was a pt incident that resulted in death. The customer stated that their "cause analysis could not determine a cause for a pt falling in the hallway, hitting her head and resulting in death. Their only conclusion was that the pt slipped and fell. The account stated that the pt was a female and healthy. The contact asked why we do not offer ted stockings with "rubber grips" on the bottom to provide traction to avoid falling. The hospital stated that their protocol is in the process of being changed to make it mandatory that all pts ambulating must have rubber grip socks on.
Patient Sequence No: 1, Text Type: D, B5
[7923529]
An investigation is currently underway, upon completion, the results will be forwarded. Per the customer, "the pt was admitted for shortness of breath. She was healthy and independent, living alone. The hospital screens all pts for risk of dvt and because of her age and other risk factors; she was placed on precaution for dvt and given teds. She was also coumadin. The hospital also screens all pts for risk of falling and determined that the pt was prone to falls. The nurses gave instructions to the pt to not get out of bed without calling for help first. The pt apparently told the nurses she would not call for help if she wanted to get up. The customer stated that the pt was being taken to ct and she does not know what she was being scanned for. The pt became unstable and the nurses assisted her to a lower position (on the floor). The pt had one bed rail on her bed. The customer stated that the pt got up to go in the bathroom unassisted and she fell. She does not know what she hit her head on. They did emergency surgery to stop the bleeding and the surgery was unsuccessful and the family took the pt off life support. Hospital protocol for pts prone to falls is giving them detailed instructions that they are not to get out of bed without calling a nurse. When the nurse gets to the pt, they would put the socks on with the rubber grips on the pt before the pt gets out of bed. The customer stated that they do not think that the teds caused the pt death. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017072-2007-00002 |
| MDR Report Key | 843908 |
| Report Source | 06 |
| Date Received | 2007-05-01 |
| Date of Report | 2007-04-06 |
| Date Reported to Mfgr | 2007-04-06 |
| Date Mfgr Received | 2007-04-06 |
| Date Added to Maude | 2007-05-04 |
| 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 |
| 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 | 3071LF TED STKG NYL T/L SS |
| Generic Name | T.E.D STOCKINGS |
| Product Code | DWL |
| Date Received | 2007-05-01 |
| Model Number | 3071LF |
| Catalog Number | 3071LF |
| Lot Number | UNK |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 831066 |
| Manufacturer | TYCO HEALTHCARE/KENDALL |
| Manufacturer Address | 1448 BLUE RIDGE BLVD SENECA SC 29672 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-05-01 |