OtherFSD
13992000 AB BNDR 9" UNIV 46-62
Received Jul 22, 2002 · Event occurred Jun 21, 2002
Report 1037420-2002-00011 · MDR key 406403
Device
Generic name
Dbg Debql Chest Products
Manufacturer
Deroyal Industries, Inc.Model number
NACatalog number
13992000
Lot number
UNK
Product problems
- Unknown (for use when the device problem is not known)
Patient
UNKNOWN
- Rash
- Treatment with medication(s)
Narrative
Description of Event or Problem
A PT DEVELOPED A RASH AFTER USING AN ABDOMINAL BINDER. PT DOESN'T KNOW IF PT IS ALLERGIC TO LATEX. PT HAS NEVER HAD A REACTION BEFORE THE BINDER WAS GIVEN TO PT AT HOSPITAL FOLLOWING HYSTERECTOMY SURGERY. PT WORE IT FROM FRIDAY UNTIL MONDAY WHEN PT CAME HOME. AFTER TAKING A SHOWER, THE RASH GOT WORSE. THE DR HAS GIVEN PT MEDICATION FOR THE RASH, AND PT NO LONGER HAS TO WEAR THE BINDER. NO REPLACEMENT BINDER IS NEEDED.
Remedial action
- Other