MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-11-24 for UNKNOWN TEDS manufactured by Covidien.
[1651771]
It was reported to covidien on (b)(6) 2010 that a customer has an issue with a ted stocking. The customer reports a pt was admitted for surgery (b)(6) 2010 for posterior spinal fusion. The pt sustained bilateral heel ulcers on (b)(6) 2010. Both heels treated with heel suspension boots and pressure relieving ankle foot orthoses "prafos". Eventually, pt needed plastic surgery to close wounds.
Patient Sequence No: 1, Text Type: D, B5
[8828048]
Submit date: (b)(4) 2010. An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017072-2010-00030 |
| MDR Report Key | 1914106 |
| Report Source | 05,06 |
| Date Received | 2010-11-24 |
| Date of Report | 2010-11-15 |
| Date of Event | 2010-09-07 |
| Report Date | 2010-11-15 |
| Date Reported to Mfgr | 2010-11-15 |
| Date Mfgr Received | 2010-11-15 |
| Date Added to Maude | 2011-02-11 |
| 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 | THOM MCNAMARA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082616625 |
| 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 | 2010-11-24 |
| Model Number | UNK |
| Catalog Number | UNK |
| 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 | 14487 BLUE RIDGE BLVD. SENECA SC 29672 US 29672 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-11-24 |