13982000 AB BNDR 12" UNIV 46-62
Received Apr 15, 2002 · Event occurred Jan 22, 2002
Report 1037420-2002-00002 · MDR key 389469
Device
Generic name
Dbg Debql Chest Products
Manufacturer
Deroyal Industries, Inc.Model number
NACatalog number
13982000
Lot number
860039
Product problems
- Reaction
Patient
UNKNOWN
- Blister(s)
- Erythema
- Rash
- Therapy/non-surgical treatment, aborted/stopped
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
BINDER MAY HAVE CAUSED A RASH ON THE PATIENT. IT WAS PUT ON PATIENT FOLLOWING SURGERY TO IMPLANT A PUMP. THE AREA COVERED BY THE INCISION SITE DRESSING WAS NOT AFFECTED, BUT ALL OTHER AREAS THAT THE BINDER TOUCHED BROKE OUT IN RED WATERY BLISTERS. THE PRODUCT WAS REMOVED, HYDROCORTIZONE CREAM WAS APPLIED AND A COTTON CORSET WAS PUT ON THE PATIENT. THESE PRODUCTS WERE SOLD TO THE HOSPITAL WHO SUPPLIED THEM TO THE PAIN CLINIC WHICH IS PART OF THE HOSPITAL. THE LOT NUMBER LISTED CAME FROM THE INVENTORY CURRENTLY ON HAND AT THE HOSPITAL, NOT THE INCIDENT.