MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2010-11-08 for TED K/L LGE REG X12 7203 manufactured by Covidien.
[19871462]
It was reported to covidien on (b)(6) 2010 that a customer had an issue with ted compression stockings. The customer states a male pt presented at the (b)(6) clinic - ultrasound confirmed calf vein thrombus in left leg. Clexane was administered on (b)(6) 2010, with warfarin administration commencing on (b)(6) 2010. The same day, a knee length ted stocking was applied to left leg after correct measurement. Stocking was removed on (b)(6) 2010, and bruising/internal bleed marking was noticed at several points from the calf with blood pooling at the ankle. The pt experienced no pain and remains treated at the (b)(6) clinic on warfarin.
Patient Sequence No: 1, Text Type: D, B5
[20099046]
(b)(4). An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9710592-2010-00002 |
| MDR Report Key | 1897548 |
| Report Source | 01,05,06 |
| Date Received | 2010-11-08 |
| Date of Report | 2010-10-25 |
| Report Date | 2010-10-25 |
| Date Reported to Mfgr | 2010-10-25 |
| Date Mfgr Received | 2010-10-25 |
| 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 STREET |
| 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 TR153Q |
| Manufacturer Country | UK |
| Manufacturer Postal Code | TR15 3Q |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TED K/L LGE REG X12 |
| Generic Name | COMPRESSION STOCKING |
| Product Code | DWL |
| Date Received | 2010-11-08 |
| Model Number | 7203 |
| Catalog Number | 7203 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2010-11-08 |