MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2012-04-26 for UNKNOWN TEDS manufactured by Covidien.
[2651381]
It was reported to covidien on (b)(6) 2012 that a customer had an issue with a ted stocking. The customer reports a pt who was wearing teds ended up having severe hematomas and wounds on their legs. The pt's wounds were dressed. There was no unanticipated tissue loss, tissue damage or bleeding.
Patient Sequence No: 1, Text Type: D, B5
[9845022]
Submit date: (b)(4) 2012. An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017072-2012-00004 |
| MDR Report Key | 2564652 |
| Report Source | 01,06 |
| Date Received | 2012-04-26 |
| Date of Report | 2012-04-05 |
| Report Date | 2011-04-05 |
| Date Reported to Mfgr | 2012-04-05 |
| Date Mfgr Received | 2012-04-05 |
| Date Added to Maude | 2012-09-14 |
| 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 | EDWARD ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE ST |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 14487 BLUE RIDGE BLVD. |
| 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 | UNKNOWN TEDS |
| Generic Name | TED STOCKING |
| Product Code | DWL |
| Date Received | 2012-04-26 |
| Model Number | UNKNOWN TEDS |
| Catalog Number | UNKNOWN TEDS |
| Lot Number | UNKNOWN |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 14487 BLUE RIDGE BLVD. SENECA SC 29672 US 29672 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-26 |