FDA.reportPublic FDA data

MAUDE MDR 3246701

MDR report key
3246701
Report number
3005225477-2013-00011
Event key
0
Event type
3
Date of event
2013-06-28
Date received
2013-07-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Address
200 DEBUSK LN. POWELL TN 37849 US
Phone
865-865-8659
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DEROYALDRESSING, COMPRESSIONDEROYAL GUATEMALAMHW13661056Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-07-1801. O

Event Narratives#

D

Patient 1

PT REPORTED THAT THEY HAD A SEVERE REACTION TO THE ABDOMINAL BINDER.

N

Patient 1

DESCRIBE EVENT OR PROBLEM: PT REPORTED THAT THEY HAD A SEVERE REACTION TO THE ABDOMINAL BINDER. DEROYAL: THE BILL OF MATERIAL FOR THE COMPONENTS OF THE PRODUCT WAS REVIEWED AND NO MATERIAL CHANGES TO THE COMPONENTS WERE IDENTIFIED FOR THE LOT NUMBER REPORTED. THE APPROPRIATE LEVEL OF SKIN CONTACT BIOCOMPATIBILITY ON THE MATERIALS WAS CONFIRMED. SENSITIZATION, IRRITATION, CYTOTOXICITY, AND LATEX PROTEIN CONCENTRATION TESTING WERE SUCCESSFULLY COMPLETED AND PASSED. FURTHERMORE, THE PRODUCT DOES NOT CONTAIN NATURAL RUBBER LATEX.