MalfunctionFSD
5151-01 ABD BNDR 30-45"
Received Dec 18, 2000 · Event occurred Nov 14, 2000
Report 1037420-2000-00005 · MDR key 309968
Device
Product problems
- Reaction
Patient
UNKNOWN
- Rash
- Therapy/non-surgical treatment, aborted/stopped
Narrative
Description of Event or Problem
AFTER APPROX WEARING THE ABDOMINAL BINDER A LITTLE OVER A WEEK, THE PT HAD TO TAKE THE PRODUCT OFF DUE TO RASH. RASH CONTINUED TO GET WORSE FOR APPROX A WEEK AFTER THE PT REMOVED THE PRODUCT. THE PT HAD BEGUN WEARING THE PRODUCT AFTER HERNIA SURGERY. THE PT RETURNED TO THE DR WHO GAVE A CREAM FOR THE RASH. THE RASH COMPLETELY COVERED WHERE THE BINDER TOUCHED AND ITCHED REALLY BAD. THE PT HAS RETURNED THE PRODUCT TO THE CO.