MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-12-07 for UNKNOWN TEDS manufactured by Covidien.
[3179600]
It was reported to covidien on (b)(6) 2012 that a customer had an issue with a repair of ted stockings. The customer reports patient had skin irritation causing a skin ulcer. The patient was referred to the wound clinic where healing was accomplished with regular wound care. The patient had to be prescribed antibiotics during the care.
Patient Sequence No: 1, Text Type: D, B5
[10316800]
An investigation is currently underway, upon completion the results will be forwarded. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017072-2012-00014 |
| MDR Report Key | 2872375 |
| Report Source | 06 |
| Date Received | 2012-12-07 |
| 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 | 2012-12-07 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| 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. Required No Informationntervention | 2012-12-07 |