DEROYAL ABDOMINAL BINDER, 9IN, S/M
Received Aug 8, 2014 · Event occurred Jun 12, 2014
Report 3005225477-2014-00018 · MDR key 4047692
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Rash
Narrative
Description of Event or Problem
PATIENT DEVELOPED A REACTION (RASH) ON THE ABDOMEN AND BACK WHERE THE ABDOMINAL BINDER HAD BEEN IN DIRECT CONTACT WITH THE PATIENT'S SKIN. PATIENT COMPLAINED OF ITCHY RASH ON HER ABDOMEN AND ON HER BACK. THE RASH WAS IN THE SHAPE OF THE BINDER; PATIENT SAID THAT THE DOCTOR KNOWS ABOUT IT AND GAVE HER A AND D OINTMENT FOR IT. PATIENT GIVEN BENADRYL P.O. FOR THE ITCHING. THE FACILITY HAS HAD ONGOING ISSUES WITH THIS DEVICE OVER THE LAST YEAR. RASHES HAVE DEVELOPED AFTER THE ABDOMINAL BINDER IS PLACED. PATIENTS IN ALL AREAS OF THE FACILITY WHERE THE PRODUCT IS USED HAVE BEEN AFFECTED. THERE IS NO APPARENT VISUAL DEFECT TO THE DEVICE. THE RASH DEVELOPS WITHIN 24 HOURS AFTER PLACEMENT ON THE PATIENT. AFFECTED PATIENTS ARE NOT ALLERGIC TO LATEX AND HAVE NO PREVIOUSLY REPORTED ALLERGIES. SOME PATIENTS HAVE REQUIRED MEDICAL INTERVENTION FOR THE RASH. THE MANUFACTURER HAS BEEN NOTIFIED AND PRODUCT HAS BEEN RETURNED. CONTRIBUTING FACTORS FOR THE RASH HAVE NOT BEEN ABLE TO BE DETERMINED. THE DEVICES ARE STORED IN TEMPERATURE CONTROLLED ENVIRONMENTS AND ARE SEALED IN THEIR INDIVIDUAL PACKAGES UNTIL NEEDED.
Additional Manufacturer Narrative
THE COMPLAINT WAS RECEIVED VIA FDA ON 07/29/2014. WE HAVE CONTACTED THE CUSTOMER, 08/07/2014 TO SEE IF PRODUCT IS STILL AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WILL PROVIDE FOLLOW UPS IF INFORMATION BECOMES AVAILABLE.