FDA.reportPublic FDA data

MAUDE MDR 2766063

MDR report key
2766063
Report number
1721293-2012-00005
Event key
0
Event type
3
Date of event
2012-07-17
Date received
2012-10-01
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
107
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MS DEBBIE MIRANDA
Address
205 HWY 22 EAST CLEAR LAKE SD 57226 US
Phone
605-605-6058
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HYBRESISHYBRESISEMPI, INC.EGJ199589-00184158Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-10-0101. O

Event Narratives#

D

Patient 1

IT WAS REPORTED TO EMPI THAT A PATIENT WAS BURNED UNDER THE BATTERY AREA OF THE HYBRESIS PATCH. THE PATIENT WAS BEING TREATED FOR TENSYNOVITIS OF ECRB/ECRL, RADIAL STYLOID, TRAPEZIUM SCAPHOID. THE COMPOUND USED WAS DEXAMETHASONE, 1.5 CC AND CONCENTRATION WAS .4%. THE DEXAMETHASONE WAS PLACED ON THE NEGATIVE SIDE OF THE PATCH AND SALINE SOLUTION WAS PLACED ON THE POSITIVE SIDE OF THE PATCH. THE MODE USED WAS HYBRESIS AND THE PATCH WAS WORN FOR TWO HOURS. THE PATIENT DID NOT FEEL PAIN OR DISCOMFORT DURING THE THERAPY. WHEN THE PATCH WAS REMOVED THE PATIENT SAW A DARK CIRCLE UNDER THE BATTERY AREA OF THE PATCH. THIS WAS A SECOND DEGREE BURN. THE PATIENT RECEIVED BASIC FIRST AID FOR THE BURN/WOUND.

N

Patient 1

THE INVESTIGATION SHOWED THAT THERE WAS A BREAK IN THE DIELECTRIC LAYER COVERING THE CONDUCTIVE TRACE IN THE FLEX CIRCUIT. THIS DEFECT COULD HAVE CAUSED THIS INJURY. THIS INCIDENT IS SIMILAR TO A COMPLAINT RECEIVED BY EMPI THAT SUGGESTS THAT THIS DEVICE MAY HAVE MALFUNCTIONED IN SUCH A WAY THAT IT COULD CAUSE A SERIOUS INJURY.