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U.S. Department of Health and Human Services

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BRAND NAMEUNNA FLEX-ELASTIC UNNA BOOT
MANUFACTURER
CONVATEC DIV. OF E.R. SQUIBB & SONS
100 HEADQUARTERS PARK DR.
SKILLMAN NJ 08858
ACCESS NUMBERM755169
PRODUCT CODEMGQ
PANELGENERAL AND PLASTIC SURGERY
REPORT TYPESERIOUS INJURY
DATE FDA RECEIVED04/18/1996
DEVICE CATALOGUE NUMBER6509-41
EVENT DESCRIPTION TYPEFINAL
EVENT DESCRIPTION
EIGHTY YR OLD MALE WITH DIAGNOSIS OF VENOUS STASIS ULCER DEVELOPED A "WATER BLISTER" ON HIS LEFT LEG FROM BELOW THE KNEE TO THE TOES AFTER WEARING THE BANDAGE FOR THREE DAYS. THE CUSTOMER WAS ADMITTED TO THE HOSP ON 4/8/96 AND WAS STARTED ON KEFLEX 250MG. PO. THE BLISTERS WERE TREATED WITH SILVADENE CREME AND DRY STERILE GAUZE. IMMEDIATELY PRIOR TO USE OF BANDAGE, THE ULCERS WERE TREATED WITH DOME PASTE AND BOOT NON DRESSING WAS SECURED WITH AN ACE BANDAGE . CUURENTLY, THE BLISTERS ARE OPEN, MEASURING 3-5CM AND GRANULATION IS REPORTED. PT HISTORY: PT HISTORY: ATHEROSCLEROSIS AND PACEMAKER IMPLANTATION. NOT RETURNED TO MFR.
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