MAUDE MDR 2015748

MDR report key
2015748
Report number
1022819-2011-00003
Event key
0
Event type
3
Date of event
2011-01-07
Date received
2011-03-07
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
116
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
1430 DECISION ST VISTA CA 92081 US
Phone
760-760-7607
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1INTELECT LEGENDNONECHATTANOOGA GROUPIMIINTC BINTC BNAN Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-03-0701. R

Event Narratives#

D

Patient 1

PT IS A FEMALE, (B)(6), WITH THE PRE-EXISTING CONDITIONS: LUMBAR STENOSIS, DIABETES, CVA WITH LEFT HEMIPLEGIA, AURALLY FOOT DROP, CAD. ON (B)(6) 2011, THE PT WAS GIVEN HER 5TH SESSION OF INTERFERENTIAL THERAPY FOR 20 MINS. THE PT DID NOT COMPLAIN DURING OR AFTER THE TREATMENT. HOWEVER SHE COMPLAINED SORENESS AND DEVELOPMENT OF A "BLISTER" WHEN SHE RETURNED FOR HER NEXT VISIT ON (B)(6) 2011. SHE RETURNED FOR 3 ADD'L PHYSICAL THERAPY SESSIONS AFTER THE INCIDENT, BUT HAS ADVICE PUT HERSELF ON "HOLD". THE TREATMENT IS TO DECREASE MUSCLE SPASM OF LEFT PIRIFORMIS. MOIST HEAT IS ALSO USED TO TREAT MUSCLE SPASM. SHE CONSULTED WOUND CARE SPECIALIST WHO ADVISED DEBRIDEMENT AS EASILY ABLE WITH TWEEZERS AND WASH CLOTH, APPLY DESITIN TO KEEP MOIST. THE CONDITION OF THE BURN IS PARTIAL THICKNESS AND SECOND DEGREE. THE PT PARTICIPATED IN EXERCISE PRIOR TO INTERFERENTIAL ESTIM AND HEAT THERAPY. SHE WAS POSITIONED IN RIGHT SIDE LYING WITH PILLOW BETWEEN HER LEGS WITH HOT PACK CLOTH OVER HER HIP AND BUTTOCK.