1937 GENTLE TOUCH PILLOW
Received Jul 11, 2006 · Event occurred Jun 21, 2006
Report 2921578-2006-00002 · MDR key 832035
Device
Generic name
Pillow
Manufacturer
Orthopedic Systems, Inc.Model number
1937Catalog number
1937
Lot number
NA
Product problems
- Unknown (for use when the device problem is not known)
Patient
*
- Erythema
- Discharge
- Injury
- Therapy/non-surgical treatment, additional
Narrative
Additional Manufacturer Narrative
IT IS UNKNOWN HOW THIS ERROR HAPPENED. OSI DISTRIBUTES THOUSANDS OF SINGLE USE PILLOWS EACH MONTH AND THIS TYPE OF PROBLEM IS RARE.
Description of Event or Problem
TWO PATIENTS SUFFERED PRESSURE INJURIES ON THEIR CHIN AND INSIDE THEIR MOUTH. ONE PATIENT WAS 7.5 HRS 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 SINCE RETURNED TO NORMAL. THE SECOND PT HAD AN ULTRASONIC RENAL CALCULI ABLATION 4.25 HOURS PRIOR AND WAS DIABETIC. TWO DAYS AFTER THE PROCEDURE HER SKIN REDDENED. SHE TOO HAS SINCE RETURNED TO NORMAL. THE CONCERN OF THE LOCATION AND THE METHOD IN WHICH THE WHITE SOFT FOAM IS ATTACHED TO THE BLUE DENSER FOAM. THERE IS A 1CM LINE OF YELLOW COLORED GLUE THAT ATTACHES THE TWO DIFFERENT MATERIALS ABOVE THE EYES AND IN THE CHIN AREA.