MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-04-22 for UNKNOWN THIGH HIGH TEDS manufactured by Covidien.
[1054906]
It was reported to covidien that a customer had an issue with teds stockings. The customer reports the patient developed a blister at the site of the top band elastic after she had stockings placed on her in the hospital. Patient was moved to nursing home and was returned to hospital with necrosis at site of previous blister. Treated with debridement and mupirocin ointment.
Patient Sequence No: 1, Text Type: D, B5
[8326080]
(b) (4). An investigation is currently underway; upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017072-2009-00003 |
| MDR Report Key | 1368455 |
| Report Source | 05,06 |
| Date Received | 2009-04-22 |
| Date of Report | 2009-03-27 |
| Report Date | 2009-03-27 |
| Date Reported to Mfgr | 2009-03-27 |
| Date Mfgr Received | 2009-03-27 |
| Date Added to Maude | 2010-03-03 |
| 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 | 1448 BLUE RIDGE BOULEVARD |
| 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 THIGH HIGH TEDS |
| Generic Name | ANTI-EMBOLISM STOCKINGS |
| Product Code | DWL |
| Date Received | 2009-04-22 |
| Model Number | UNK |
| Catalog Number | UNK |
| 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 | 1448 BLUE RIDGE BOULEVARD SENECA SC 29672 US 29672 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-04-22 |