MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-12-06 for UNKNOWN TEDS manufactured by Covidien.
[3178655]
It was reported to covidien on (b)(6) 2012 that a customer had an issue with a pair of ted stockings. The customer reports the patient had skin irritation causing a skin ulcer. The patient was sent to the wound center for wound treatment, which las led to prolonged hospital stay and healing time.
Patient Sequence No: 1, Text Type: D, B5
[10531988]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017072-2012-00013 |
| MDR Report Key | 2872338 |
| Report Source | 05,06 |
| Date Received | 2012-12-06 |
| Date of Report | 2012-11-08 |
| Report Date | 2012-11-08 |
| Date Reported to Mfgr | 2012-11-08 |
| Date Mfgr Received | 2012-11-08 |
| Date Added to Maude | 2013-01-03 |
| 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 | JILL SARAIVA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524970 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 14487 BLUE RIDGE BLVD. |
| 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 TEDS |
| Generic Name | TED |
| Product Code | DWL |
| Date Received | 2012-12-06 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 14487 BLUE RIDGE BLVD. SENECA SC 29672 US 29672 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2012-12-06 |