MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-03-30 for UNKNOWN TEDS manufactured by Covidien Lp.
[1095872]
It was reported to covidien in 2009, that a customer has an issue with a ted stocking. The customer states that pt developed a deep tissue injury on one foot. Customer states pt had a small bruise on each metatarsal.
Patient Sequence No: 1, Text Type: D, B5
[8356125]
Submit date: 03/27/2009. An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017072-2009-00002 |
| MDR Report Key | 1423025 |
| Report Source | 05,06 |
| Date Received | 2009-03-30 |
| Date of Report | 2009-03-23 |
| Date of Event | 2009-03-23 |
| Report Date | 2009-03-20 |
| Date Reported to Mfgr | 2009-03-23 |
| Date Mfgr Received | 2009-03-23 |
| Date Added to Maude | 2009-09-18 |
| 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 | THOM MCNAMARA |
| Manufacturer Street | 15 HAMPSHIRE ST. |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082616625 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 1448 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 STOCKING |
| Product Code | DWL |
| Date Received | 2009-03-30 |
| Model Number | UNK |
| Catalog Number | UNK |
| 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 LP |
| Manufacturer Address | 1448 BLUE RIDGE BLVD. SENECA SC 29672 US 29672 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-03-30 |