OtherFSD
LF-C2FMS-M-100 1.5X36" 100 SET
Received Sep 6, 2013
Report 9681860-2013-00021 · MDR key 3338561
Device
Product problems
- No Apparent Adverse Event
Patient
UNK
- Skin Irritation
Narrative
Description of Event or Problem
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2013 THAT A CUSTOMER HAD AN ISSUE WITH AN ABDOMINAL BELT. THE CUSTOMER STATED THAT ONE OF HER PATIENTS HAD A REACTION TO ONE OF THE BELTS THAT WAS USED WHILE THE PATIENT WAS IN THE HOSPITAL. THE REACTION LOOKED LIKE A RED RASH WITH PUSTULES. MEDICATION WAS PRESCRIBED, NIZORAL 2% CREAM TO WASH THE BODY AND TRIAMCINOLONE 1% CREAM.
Additional Manufacturer Narrative
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.