MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2012-07-16 for UNKNOWN TEDS UNK TEDS manufactured by Covidien.
[15153398]
It was reported to covidien on (b)(6) 2012 that a customer had an issue with a ted compression stocking. The customer states post-op, the pt has experienced ulcers on both feet as a consequence of pressure from the ted stockings.
Patient Sequence No: 1, Text Type: D, B5
[15273416]
Submit date: (b)(4) 2012. An investigation is currently underway. Upon completion, the results will be voided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017072-2012-00008 |
| MDR Report Key | 2665513 |
| Report Source | 01,06 |
| Date Received | 2012-07-16 |
| Date of Report | 2012-06-19 |
| Date of Event | 2011-09-26 |
| Report Date | 2012-06-19 |
| Date Reported to Mfgr | 2012-06-19 |
| Date Mfgr Received | 2012-06-19 |
| Date Added to Maude | 2012-07-30 |
| 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 ALMEDIA |
| Manufacturer Street | 15 HAMPSHIRE ST. |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 1448 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 COMPRESSION STOCKING |
| Product Code | DWL |
| Date Received | 2012-07-16 |
| Model Number | UNK TEDS |
| Catalog Number | UNK TEDS |
| Lot Number | UNK |
| 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 | 1. Other | 2012-07-16 |