ABDOMINAL BINDER
Received Apr 4, 2014 · Event occurred Feb 14, 2014
Report 3732940 · MDR key 3732940
Device
Generic name
Abdominal Binder
Manufacturer
Deroyal Industries Inc.Model number
*Catalog number
A131067
Lot number
33405709
Product problems
- Patient-Device Incompatibility
Patient
34 YR
- Rash
Narrative
Description of Event or Problem
RASH DEVELOPED WHERE ABDOMINAL BINDER WAS LOCATED. 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.