FDA.reportPublic FDA data

MAUDE MDR 3300841

MDR report key
3300841
Report number
3005225477-2013-00016
Event key
0
Event type
3
Date of event
2013-07-05
Date received
2013-08-09
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
865-865-8659
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DEROYALMHW - DRESSING, COMPRESSIONDEROYAL GUATEMALAMHWA13105631622021Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-08-0901. O

Event Narratives#

D

Patient 1

ABDOMINAL BINDER CAUSED ITCHING AND RASH. RASH LIGHT PINK WITHOUT BLISTERS. RASH WAS ALL OVER THE AREA WHERE BINDER WAS TOUCHING SKIN. THIS FACILITY HAS HAD MORE THAN 7 SIMILAR EVENTS WITH THIS PRODUCT IN THE LAST 5 MONTHS. PRODUCT STATES LATEX FREE. THE FACILITY REPORTS THIS TYPE OF REACTION HAS BEEN SEEN IN PTS WITH C-SECTIONS AS WELL AS VAGINAL DELIVERIES; THUS STAFF DOES NOT BELIEVE THAT THERE IS A REACTION TO THE SKIN PREP USED FOR C-SECTION DELIVERIES BECAUSE THE PREP IS NOT USED IN A VAGINAL DELIVERY. ALSO, STAFF HAS STATED IN PREVIOUS INCIDENTS HAT THE RASH OCCURS ON AREAS WHICH DOES NOT HAVE THE SKIN PREP BUT DOES HAVE CONTACT WITH THE BINDER. PTS WITH AND WITHOUT KNOWN ALLERGIES HAVE BEEN AFFECTED. THE MANUFACTURER HAS BEEN NOTIFIED. WE CHECKED WITH OUR SURGICAL UNIT BECAUSE THEY USE QUITE A FEW ABDOMINAL BINDERS ND THEY HAVE NOT HEARD OF ANY CONCERNS REGARDING RASH. PATIENTS IN THE SURGICAL UNIT WOULD HAVE SIMILAR USE OF THIS DEVICE. ALSO, THERE ARE PTS IN THE SURGICAL UNIT WHO HAVE AND WHO HAVE NOT HAD EXPOSURE TO THE SAME BRAND OF SKIN PREP AS THE PTS ON THE OTHER UNIT. THE STORAGE PROCEDURE/PROCESS FOR BOTH NURSING UNITS IS IDENTICAL: STORAGE AND TRANSPORTATION OF THE DEVICES ARE NOT BELIEVED TO BE CONTRIBUTING FACTORS IN THESE EVENTS.

N

Patient 1

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. FURTHERMORE, THE PRODUCT DOES NOT CONTAIN NATURAL RUBBER LATEX.