ABDOMINAL BINDER
Received Apr 4, 2014 · Event occurred Feb 20, 2014
Report 3732939 · MDR key 3732939
Device
Generic name
Abdominal Binder
Manufacturer
Deroyal Industries IncModel number
*Catalog number
A131056
Lot number
33405645
Product problems
- Patient-Device Incompatibility
Patient
40 YR
- Rash
Narrative
Description of Event or Problem
PATIENT PUT ABDOMINAL BINDER ON DIRECTLY TO HER SKIN LAST NIGHT AND EARLY IN THE MORNING. THE RN WAS CALLED INTO THE ROOM AND PATIENT HAD RASHES WHERE THE BINDER WAS APPLIED. THIS FACILITY HAS HAD ONGOING ISSUES WITH THIS DEVICE. MULTIPLE PATIENTS HAVE BEEN INVOLVED OVER APPROXIMATELY 1 YEAR. PATIENTS WHO HAVE HAD C-SECTIONS AND THOSE WHO HAVE HAD VAGINAL DELIVERIES HAVE BEEN AFFECTED. THE FACILITY DOES NOT KNOW WHY THIS IS OCCURRING. PATIENTS WITH AND WITHOUT KNOWN ALLERGIES HAVE BEEN AFFECTED. THE FACILITY HAS NOTIFIED THE MANUFACTURER IN THE PAST AND HAS RETURNED PRODUCT. THE PROBLEM PERSISTS.