MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2012-07-11 for UNK TEDS manufactured by Covidien.
[21296399]
It was reported to covidien on 06/19/2012 that a customer had an issue with a ted compression stocking. The customer states that the pt has a wound on the right ankle where the stocking was being worn. The pt had hip prosthesis surgery and is experiencing numbness in the legs. The pt is diabetic and is treated with insulin. The customer states that the spinal may have caused the numbness.
Patient Sequence No: 1, Text Type: D, B5
[21350252]
Submit date: 07/11/2012. An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009211636-2012-00001 |
| MDR Report Key | 2659583 |
| Report Source | 01,06 |
| Date Received | 2012-07-11 |
| Date of Report | 2012-06-19 |
| Date of Event | 2011-04-24 |
| Report Date | 2012-06-19 |
| Date Reported to Mfgr | 2012-06-19 |
| Date Mfgr Received | 2012-06-19 |
| Date Added to Maude | 2012-07-31 |
| 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 ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE ST. |
| Manufacturer City | MANSFIELD MA 020480000 |
| Manufacturer Country | US |
| Manufacturer Postal | 020480000 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN MANUFACTURING SOLUTIONS SA |
| Manufacturer Street | EDIFICIO B20 CALLE 2 ZONA FRANCA COYOL |
| Manufacturer City | ALAJUELA 20101 |
| Manufacturer Postal Code | 20101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK TEDS |
| Generic Name | TED COMPRESSION STOCKING |
| Product Code | DWL |
| Date Received | 2012-07-11 |
| Model Number | UNK TED |
| Catalog Number | UNK TED |
| 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 | COVIDIEN MFG ALAJUELA 20101 20101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-07-11 |