OtherISH
SL8001-05 SAMSON MEDIUM
Received May 29, 2002 · Event occurred Apr 24, 2002
Report 1122762-2002-00003 · MDR key 397873
Device
Generic name
Tda Three-d Foot Products
Manufacturer
Deroyal Industries, Inc.Model number
NACatalog number
SL8001-05
Lot number
UNK
Product problems
- Reaction
Patient
UNKNOWN
- Blister(s)
- Erythema
- Pain
- Reaction
- Skin Tears
- Therapy/non-surgical treatment, additional
- Treatment with medication(s)
Narrative
Description of Event or Problem
THE PT BROKE OUT IN PAINFUL BLISTERS THAT BECAME SHINY AND RED AFTER WEARING THE WALKER FOR ONE WEEK. NOW THE WHOLE LEG IS SPLIT AND/OR CRACKED OPEN IN PLACES PT'S DR PRESCRIBED AN OINTMENT YESTERDAY. PT IS ALSO DIABETIC. PT WANTS TO KNOW THE MATERIAL MAKE-UP OF THE DEVICE. THE PRODUCT NUMBER MAY BE INCORRECT. IT WAS DETERMINED BY THE DESCRIPTION OF THE PRODUCT GIVEN TO STAFF PERSON BY THE PT. REPLACEMENT OF B-PRODUCT AND 1 ROLL STOCKINETTE WILL BE SENT OVERNIGHT. UPS WILL PICK UP PRODUCT FOR RETURN TO THE CO.