MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-08-22 for T.E.D. ANTI-EMBOLISM STOCKINGS ALL KNEE HIGH AND THIGH HIGH MODELS ALL KNEE HIGH AND THIGH HIGH manufactured by Covidien Llc.
[2267503]
Covidien has switched the packaging used on all ted hose products. Covidien purchased tyco healthcare, which had the previous labeling. The ted hose products remain the same; however, the new covidien packaging does not showcase the sizes as well as before when the products were labeled by tyco healthcare. On the new covidien label, the size is in fine print on the far left english line, about 2/3 of the way down on the back of the package, has the size listed but not what that means in centimeters around the thigh or calf. User must go to the back of the original package and read the instructions. On the previous tyco kendall packaging, the sizes and measurements are printed on the front and back of the package in yellow boxes, easy to find. Hospital has a photocopy of the front and back of the two versions of the packaging. Nursing is using a tyco healthcare sizing chart to help staff select the appropriate size of ted hose for patient use and has posted a laminated covidien t. E. D. Anti-embolism stocking chart in storerooms that stock these covidien-labeled stockings.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2225313 |
| MDR Report Key | 2225313 |
| Date Received | 2011-08-22 |
| Date of Report | 2011-08-22 |
| Date of Event | 2011-08-16 |
| Report Date | 2011-08-22 |
| Date Reported to FDA | 2011-08-22 |
| Date Added to Maude | 2011-08-29 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | T.E.D. ANTI-EMBOLISM STOCKINGS |
| Generic Name | ANTI-EMBOLISM STOCKINGS (TED HOSE) |
| Product Code | DWL |
| Date Received | 2011-08-22 |
| Model Number | ALL KNEE HIGH AND THIGH HIGH MODELS |
| Catalog Number | ALL KNEE HIGH AND THIGH HIGH |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LLC |
| Manufacturer Address | 1448 BLUE RIDGE BLVD SENECA SC 29672 US 29672 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-22 |