MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2010-08-10 for 3416LF TED STKG NYL T/L MR manufactured by Covidien.
[1358331]
It was reported to covidien on (b)(6) 2010 that a customer had an issue with a ted stocking. The customer reports bilateral varicose veins on pt's legs ruptured after use of ted stockings. The pt had previously been given therapeutic heparin for possible pe.
Patient Sequence No: 1, Text Type: D, B5
[8669037]
Submit date: 8/10/2010. An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9710592-2010-00001 |
| MDR Report Key | 1803543 |
| Report Source | 01,06 |
| Date Received | 2010-08-10 |
| Date of Report | 2010-07-19 |
| Date of Event | 2010-07-10 |
| Report Date | 2010-07-19 |
| Date Reported to Mfgr | 2010-07-19 |
| Date Mfgr Received | 2010-07-19 |
| Date Added to Maude | 2011-04-28 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | JUDITH SHAW, RN |
| Manufacturer Street | 15 HAMPSHIRE ST. |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | WILSON WAY POOL INDUSTRIAL ESTATE |
| Manufacturer City | CORNWALL TR15 |
| Manufacturer Country | UK |
| Manufacturer Postal Code | TR15 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3416LF TED STKG NYL T/L MR |
| Generic Name | COMPRESSION STOCKINGS |
| Product Code | DWL |
| Date Received | 2010-08-10 |
| Model Number | 3416LF |
| Catalog Number | 3416LF |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | WILSON WAY CORNWALL TR153Q UK TR15 3Q |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-08-10 |