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U.S. Department of Health and Human Services

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Type of Device:
Anti-embolism stockings (TED Hose)
Device Brand Name:
T.E.D. anti-embolism stockings
Device Manufacturer's Name:
Covidien LLC
Date of this Report:
(mm/dd/yyyy)
08/22/2011
Describe the Event
or Problem:
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.
the device(s) may have
caused or contributed to:
Not applicable
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