MalfunctionFSD
DEROYAL ABDOMINAL BINDER
Received Jun 3, 2014 · Event occurred May 13, 2014
Report 3005225477-2014-00013 · MDR key 3957948
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Rash
Narrative
Description of Event or Problem
PATIENT DEVELOPED RASH FROM ABDOMINAL BINDER. THIS FACILITY HAS HAD ONGOING ISSUES WITH THE DEVICE. RASHES HAVE DEVELOPED AFTER THE ABDOMINAL BINDER IS PLACED ON BOTH C-SECTION AND VAG DELIVERY PATIENTS. THIS PRODUCT ALSO IS USED AT THIS FACILITY IN THE SURGICAL UNIT. UNTIL RECENTLY, SURGICAL PATIENTS HAD NOT BEEN AFFECTED. HOWEVER, ONE CASE OF A SURGICAL PATIENT WITH A SIMILAR EVENT DID HAPPEN RECENTLY. AFFECTED PATIENTS ARE NOT ALLERGIC TO LATEX AND HAVE NO PREVIOUSLY REPORTED ALLERGIES. SOME PATIENTS HAVE REQUIRED MEDICAL INTERVENTION FOR THE RASH.