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.
[1651315]
It was reported to covidien on (b)(6) 2010 that a customer has an issue with a ted stocking. The customer reports that the pt had lumbar decompression and lumbar fusion on (b)(6) 2009. The pt sustained bilateral heel pressure sores stage 2. Right 10. 5 cm x 7 cm. Left 8. 5 cm x 9. 5 cm. Physician opened blisters and treated with adaptic. Pt eventually needed plastic surgery to close heel wounds. At 6 months, the right heel was healed, left heel still open. At 9 months, no mention of either heel wound.
Patient Sequence No: 1, Text Type: D, B5
[8827545]
(b)(4). An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017072-2010-00034 |
| MDR Report Key | 1914055 |
| Report Source | 05,06 |
| Date Received | 2010-11-24 |
| Date of Report | 2010-11-15 |
| Date of Event | 2010-12-07 |
| 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 | DA |
| 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 | 2010-11-24 |