MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2012-07-12 for UNKNOWN TEDS manufactured by Covidien, Covidien Manufacturing.
[21261625]
It was reported to covidien on (b)(6) 2012 that a customer had an issue with a ted compression stocking. The customer states that the stockings were used during hip surgery. The patient experienced a pressure wound/decubitus above the heel where the stocking had been tight.
Patient Sequence No: 1, Text Type: D, B5
[21357430]
Submit date: (b)(4) 2012. An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009211636-2012-00003 |
| MDR Report Key | 2665117 |
| Report Source | 01,06 |
| Date Received | 2012-07-12 |
| Date of Report | 2012-06-19 |
| Date of Event | 2011-04-01 |
| Report Date | 2012-06-19 |
| Date Reported to Mfgr | 2012-06-19 |
| Date Mfgr Received | 2012-06-19 |
| Date Added to Maude | 2012-10-26 |
| 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 STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN, COVIDIEN MANUFACTURING SOLULFONS SA |
| Manufacturer Street | EDIFICIO 820 CALLE #2 ZONA FRANCA |
| 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 | UNKNOWN TEDS |
| Generic Name | TED COMPRESSION STOCKING |
| Product Code | DWL |
| Date Received | 2012-07-12 |
| Model Number | UNKNOWN TED |
| Catalog Number | UNKNOWN TED |
| Lot Number | UNKNOWN |
| 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, COVIDIEN MANUFACTURING |
| Manufacturer Address | ALAJUELA 20101 CS 20101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-07-12 |