ABDOMINAL BINDER
Received Jul 17, 2014 · Event occurred Jul 16, 2014
Report 3973227 · MDR key 3973227
Device
Product problems
- Patient-Device Incompatibility
Patient
35 YR
- Rash
- Reaction
Narrative
Description of Event or Problem
PT S/P C-SECTION DEVELOPED RASH ON ABDOMEN TWO DAYS AFTER ABDOMINAL BINDER WAS IN PLACE. MD WAS CALLED ABOUT RASH AND ABDOMINAL BINDER WILL NOT BE REAPPLIED TO PATIENT.STAFF DID NOT SAVE THE PACKAGING SO THE LOT AND REF NUMBER ARE UNAVAILABLE. HOWEVER, THIS FACILITY HAS HAD MULTIPLE SIMILAR PROBLEMS WITH THIS DEVICE. PATIENTS HAVE DEVELOPED A SIMILAR RASH WITHIN 24-48 HOURS OF PLACEMENT OF THE ABDOMINAL BINDER. PREVIOUS PRODUCT HAS BEEN RETURNED TO THE MANUFACTURER. STAFF AND MANUFACTURER DO NOT KNOW WHAT IS CAUSING THIS PROBLEM.