MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-02-24 for T.E.D. ANTIEMBOLISM STOCKINGS KNEE LENGTH * manufactured by Covidien, Formerly Kendall, A Division Of Tyco Healthcare.
[5459144]
The patient delivered a full term infant and per usual plan of care had t. E. D. Knee length stockings placed. Postpartum, she complained of pain in her left foot and ankle. When the nurse pulled the foot part of the t. E. D. Stockings up, there was a blister on the front of the left ankle. Since discharge, the patient has developed a scar across the front of her ankle. She states that she continues to have pain from the scar and will be consulting with a plastic surgeon in the future.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4557813 |
| MDR Report Key | 4557813 |
| Date Received | 2015-02-24 |
| Date of Report | 2014-12-19 |
| Date of Event | 2014-03-03 |
| Report Date | 2014-12-19 |
| Date Reported to FDA | 2015-02-24 |
| Date Reported to Mfgr | 2015-03-02 |
| Date Added to Maude | 2015-03-02 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | T.E.D. ANTIEMBOLISM STOCKINGS KNEE LENGTH |
| Generic Name | STOCKING, MEDICAL SUPPORT (TO PREVENT POOLING OF BLOOD IN LE |
| Product Code | DWL |
| Date Received | 2015-02-24 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN, FORMERLY KENDALL, A DIVISION OF TYCO HEALTHCARE |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-24 |