MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-12-16 for 3416LF TED STKG NYL T/L MR manufactured by Covidien.
[15537313]
It was reported to covidien on 12/04/2009 that a customer had an issue with a ted compression stocking. The customer reports after wearing the stockings for one week (and washing them once) she began to get pinpoint spots on her legs, which progressed to welts, which then developed into a rash. Her doctor prescribed triamcinolone and benadryl for an allergic reaction.
Patient Sequence No: 1, Text Type: D, B5
[15892716]
(b) (4). An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017072-2009-00015 |
| MDR Report Key | 1562887 |
| Report Source | 04 |
| Date Received | 2009-12-16 |
| Date of Report | 2009-12-04 |
| Report Date | 2009-12-04 |
| Date Reported to Mfgr | 2009-12-04 |
| Date Mfgr Received | 2009-12-04 |
| Date Added to Maude | 2010-05-18 |
| 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 | 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 | 3416LF TED STKG NYL T/L MR |
| Generic Name | TED COMPRESSION STOCKING |
| Product Code | DWL |
| Date Received | 2009-12-16 |
| Model Number | 3416LF |
| Catalog Number | 3416LF |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 | 1. Other | 2009-12-16 |