MAUDE MDR 730365

MDR report key
730365
Report number
730365
Event key
0
Event type
3
Date received
2006-06-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GENTLETOUCH 7' HEADREST PILLOW WITH RIGHT INTUBATION SLOTPILLOW, FOAMORTHROPEDIC SYSTEMS, INC.KME1937*10/26/05 AND 11/16/05NR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12006-06-210

Event Narratives#

D

Patient 1

TWO PATIENTS SUFFERED PRESSURE INJURIES ON THEIR CHIN AND INSIDE THEIR MOUTH. ONE PATIENT WAS 7.5 HOURS POST-OPERATIVE AFTER HAVING AN ULTRASONIC RENAL CALCULI ABLATION, AND WAS IN GOOD HEALTH. TWO DAYS AFTER THE PROCEDURE, HIS CHIN BECAME REDDENED AND STARTED LEAKING SEROUS FLUID THAT BECAME SCABBED. HE LOST SENSATION ON HIS CHIN, BUT HAS SINCE RETURNED TO NORMAL. THE SECOND PATIENT HAD AN ULTRASONIC RENAL CALCULI ABLATION 4.25 HOURS PRIOR AND WAS DIABETIC. TWO DAYS AFTER THE PROCEDURE HER SKIN WAS REDDENED. SHE TOO HAS SINCE RETURNED TO NORMAL.THE CONCERN IS THE LOCATION AND THE METHOD IN WHICH THE WHITE SOFT FOAM IS ATTACHED TO THE BLUE DENSER FOAM. THERE IS A 1 CM LINE OF YELLOW COLORED GLUE THAT ATTACHES THE TWO DIFFERENT MATERIALS ABOVE THE EYES AND IN THE AREA BELOW THE CHIN REST. THIS GLUE LINE IS HARD AND ROUGH.