FDA.reportPublic FDA data

MAUDE MDR 4047692

MDR report key
4047692
Report number
3005225477-2014-00018
Event key
0
Event type
3
Date of event
2014-06-12
Date received
2014-08-08
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Address
200 DEBUSK LANE POWELL TN 37849 US
Phone
865-865-8653
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DEROYAL ABDOMINAL BINDER, 9IN, S/MBINDER, ABDOMINALDEROYAL GUATEMALAFSDA13105635159679R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-08-0801. R

Event Narratives#

D

Patient 1

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.

N

Patient 1

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.