MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2012-03-16 for T.E.D. 7802 manufactured by Covidien.
[2553987]
It was reported to covidien on (b)(6) 2012 that a customer had an issue with a anti-embolism stocking. The customer reports the pt was submitted to neuro surgery because she has a meningeal tumor. The surgery took approx 9 hours counting time of anesthesia induction. As prophylaxis, anti-embolism stockings and intermittent pneumatic compression system were used. The pt was subsequently transferred to the intensive care unit, post-operative the pt inferred inability of the left foot movement, the pt is assessed by the treating physician who reports a possible neuropraxia of the peroneal nerve or popliteal sciatic left.
Patient Sequence No: 1, Text Type: D, B5
[9763314]
Submit date: (b)(6) 2012. An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017072-2012-00003 |
| MDR Report Key | 2496525 |
| Report Source | 01,06 |
| Date Received | 2012-03-16 |
| Date of Report | 2012-03-05 |
| Report Date | 2012-03-05 |
| Date Reported to Mfgr | 2012-03-05 |
| Date Mfgr Received | 2012-03-05 |
| Date Added to Maude | 2012-08-30 |
| 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 ST |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| 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 | T.E.D. |
| Generic Name | ANTI-EMBOLISM STOCKING |
| Product Code | DWL |
| Date Received | 2012-03-16 |
| Model Number | 7802 |
| Catalog Number | 7802 |
| Lot Number | 1228C7DX |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| 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 | 2012-03-16 |