MAUDE MDR 5243431

MDR report key
5243431
Report number
MW5058010
Event key
0
Event type
3
Date of event
2015-11-12
Date received
2015-11-19
Adverse event
0
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HEATING UNITHEATING UNITCHECK CORPORATIONIRQ* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-11-1901. O

Event Narratives#

D

Patient 1

A (B)(6) Y/O FEMALE RECEIVING A BLOOD TRANSFUSION WAS SITTING IN A RECLINER CHAIR WITH A PILLOW BEHIND HER BACK. THE CHAIR WAS EQUIPPED WITH A MASSAGER AND HEATING UNIT. PT WAS TESTING, WHEN SHE STARTED TO FEEL HOT. HER HUSBAND WAS WITH HER DURING THE TRANSFUSION. WHEN SHE SAT FORWARD, SHE NOTICED SMOKE COMING FROM THE PILLOW. HUSBAND HELPED HER TO STAND UP AND GET OUT OF THE CHAIR. HE EXITED THE ROOM STATING "THE CHAIR IS ON FIRE!" SHE WAS ASSESSED BY 2 PROVIDERS IMMEDIATELY. A 20CM X 20CM AREA ON HER BACK WAS REDDENED. SILVADENE WAS PRESCRIBED, WITH ORDERS TO APPLY 2 TIMES DAILY, TOPICALLY. ASSESSMENT BY WOUND CARE DOCTOR ON THE FOLLOWING DAY FOUND A DORSAL TRUNK BURN, REPORTEDLY A SECOND-DEGREE, HOWEVER NO LONGER HAS ANY ERYTHEMA OR IRRITATION, AND CERTAINLY NO SKIN LOSS OR BLISTERING. THIS WAS LIKELY A FIRST-DEGREE IRRIGATION/BURN AND SHE WILL SIMPLY MOISTURIZE DAILY FOR A FEW DAYS AND THEN PRN. PT WILL F/U WITH WOUND CARE DOCTORS AS NEEDED. DATES OF USE: 2.5 YEARS. REASON FOR USE: CHAIRS USED BY PTS AT CANCER CLINIC RECEIVING CHEMO.