MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-11-05 for T.E.D. 3221 manufactured by Covidien Manufacturing Solutions Sa.
[3976241]
It was reported to covidien on (b)(6) 2013 that a customer had an issue with a t. E. D. Stocking. The customer states that the stocking was rolling down and cutting into patient's thigh. The stocking was removed. The patient developed an open ulceration on inside of right upper thigh. Stockings were not available to be returned.
Patient Sequence No: 1, Text Type: D, B5
[11308529]
Submit date: 11/05/2013. An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009211636-2013-00004 |
| MDR Report Key | 3540021 |
| Report Source | 06 |
| Date Received | 2013-11-05 |
| Date of Report | 2013-11-05 |
| Date of Event | 2013-10-29 |
| Report Date | 2013-11-05 |
| Date Reported to Mfgr | 2013-11-05 |
| Date Mfgr Received | 2013-11-05 |
| Date Added to Maude | 2014-02-04 |
| 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 | LAWRENCE ROCK |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082616625 |
| Manufacturer G1 | COVIDIEN MANUFACTURING SOLULFONS SA |
| Manufacturer Street | EDIFICIO B20 CALLE 2 ZONA FRANCA COYOL |
| Manufacturer City | ALAJUELA 20101 |
| Manufacturer Country | CS |
| Manufacturer Postal Code | 20101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | T.E.D. |
| Generic Name | T.E.D. |
| Product Code | DWL |
| Date Received | 2013-11-05 |
| Model Number | 3221 |
| Catalog Number | 3221 |
| 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 MANUFACTURING SOLUTIONS SA |
| Manufacturer Address | EDIFICIO B20 CALLE 2 ZONA FRANCA COYOL ALAJUELA 20101 CS 20101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-05 |