MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2011-10-03 for KNEE LENGTH MED/REG TED 7115 manufactured by Covidien.
[2216317]
It was reported to covidien on (b)(6) 2011 that a customer had an issue with a pair of ted stockings. The customer stated that a pt had an allergic reaction (shortness of breath, itching and hives) to the t. E. D. Anti embolism stockings. The pt had a known allergic reaction to latex. The pt was sent to the emergency room where she was given an iv and prescription medications.
Patient Sequence No: 1, Text Type: D, B5
[9432098]
Submit date: (b)(4) 2011. An investigation is currently underway, upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017072-2011-00009 |
| MDR Report Key | 2288548 |
| Report Source | 01 |
| Date Received | 2011-10-03 |
| Date of Report | 2011-09-15 |
| Report Date | 2011-09-15 |
| Date Reported to Mfgr | 2011-09-15 |
| Date Mfgr Received | 2011-09-15 |
| Date Added to Maude | 2012-07-06 |
| 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 | 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 | KNEE LENGTH MED/REG TED |
| Generic Name | TED ANTI EMBOLISM STOCKINGS |
| Product Code | DWL |
| Date Received | 2011-10-03 |
| Model Number | 7115 |
| Catalog Number | 7115 |
| Lot Number | 66975746 |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 1448 BLUE RIDGE BLVD. SENECA SC 29672 US 29672 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-10-03 |