FDA.reportPublic FDA data

MAUDE MDR 3261621

MDR report key
3261621
Report number
1721293-2013-00003
Event key
0
Event type
3
Date of event
2013-07-02
Date received
2013-08-02
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
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
1ACTION PATCHACTION PATCHEMPI, INC.EGJ199488-00192271N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-08-0201. O

Event Narratives#

D

Patient 1

IT WAS REPORTED TO EMPI THAT A PATIENT WAS BURNED USING AN ACTION PATCH. THE PATIENT'S DIAGNOSIS WAS, FLEXOR CARPI ULNARIS (FCU) TENDONITIS OF THE RIGHT ARM. THIS WAS THE 3RD TREATMENT. THE THERAPY PERFORMED PRIOR TO TREATMENT WAS PFN, STRETCHING AND BTE. THE SKIN WAS WASHED AND DRIED PRIOR TO THE TREATMENT. THE COMPOUND USED WAS DEXAMETHASONE, 2.0ML, THE CONCENTRATION WAS 10%. THE PATCH WAS APPLIED BY A HEALTH PROFESSIONAL. THE PATCH HAD A LITE PRE-WRAP PLACED ON THE ELECTRODE AND WAS WORN FOR 5 HOURS. THE PATIENT REPORTED THAT THERE WAS NO PAIN DURING THE TREATMENT, BUT THOUGHT IT MAY HAVE BEEN A LITTLE ITCHER THAN THE PREVIOUS TREATMENTS. THE IRRITATION WAS NOTICED UPON REMOVAL OF THE ELECTRODE, IT WAS UNDER THE BATTERY AREA OF THE ELECTRODE. THE PATIENT DESCRIBED THE IRRITATION AS "BLOODY HOLES" THAT LATER SCABBED OVER. AFTER 2 DAYS THE SURROUNDING AREA BECAME RED, RAISED, AND ITCHY. THE BURN WAS SAID TO BE 1ST DEGREE. THE IRRITATION LASTED 3-4 WEEKS. THE PATIENT DID NOT RECEIVE MEDICAL TREATMENT FOR THE INCIDENT, PATIENT PURCHASED BENADRYL CREAM AND NEOSPORIN.

N

Patient 1

THIS IS AN UNUSUAL EVENT. THE SUSPECT DEVICE WAS NOT RETURNED FOR EMPI TO EVALUATE. PHOTOS OF THE AFFECTED AREA WERE PROVIDED WHICH SHOWED NINE SMALL (.1-.2") CIRCULAR SECOND DEGREE BURNS SPREAD OVER A REDDENED AREA. THEN THERE IS ONE SMALL BURN OUTSIDE OF THAT AREA. THE AFFECTED AREA WAS UNDER THE POSITIVE ELECTRODE GEL. THE PATIENT AND CLINICIAN BOTH CONFIRMED THAT THE KARAYA GEL WAS PRESENT ON THE PATCH. PATIENT DISPOSED OF THE ELECTRODE.