DEROYAL
Received Apr 22, 2013 · Event occurred Mar 21, 2013
Report 3005225477-2013-00002 · MDR key 3136349
Device
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- Erythema
- Hypersensitivity/Allergic reaction
- Urticaria
Narrative
Description of Event or Problem
THE HOSPITAL REPORTED THAT THEY ARE HAVING SEVERAL PATIENTS GET BAD REACTIONS TO THE ABDOMINAL BINDER. PATIENTS HAVE BROKE OUT IN RED BLOTCHES AND THERE WAS ONE PATIENT THAT GOT HIVES. THEY HAD TO GIVE THIS PATIENT STEROID CREAM AND BENADRYL. IT COULD BE THE BINDER OR THE SKIN PREP CAUSING THE PROBLEM.
Additional Manufacturer Narrative
THE HOSPITAL REPORTED THAT THEY ARE HAVING SEVERAL PATIENTS GET BAD REACTIONS TO THE ABDOMINAL BINDER. PATIENTS HAVE BROKE OUT IN RED BLOTCHES AND THERE WAS ONE PATIENT THAT GOT HIVES. THEY HAD TO GIVE THIS PATIENT STEROID CREAM AND BENADRYL. DEROYAL: THE DEFECTIVE SAMPLES WERE NOT RETURNED TO THE MANUFACTURER. THE ABDOMINAL BINDER IS LATEX FREE AND HAS HAD NO NEW MATERIAL CHANGES. A ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE.