JAY CUSHION

Additional Manufacturer Narrative

UDI RELATED DATA QUALITY UPDATES ONLY. THIS MDR ONLY CONTAINED THE DI PORTION OF THE UDI INCLUDED IN THE MEDWATCH FORM. THE MDR HAS BEEN CORRECTED BY ADDING THE FULL UDI NUMBER.

Description of Event or Problem

THIS REPORT REPRESENTS A CORRECTION TO A PREVIOUSLY SUBMITTED MDR.

Additional Manufacturer Narrative

BACKGROUND INFORMATION: JAY J2 DEEP CONTOUR CUSHION OWNER'S MANUAL REV. D, PAGE 2 STATES: "WARNING! PRIOR TO PROLONGED SITTING, ANY CUSHION SHOULD BE TRIED FOR A FEW HOURS AT A TIME WHILE A CLINICIAN INSPECTS YOUR SKIN TO ENSURE THAT RED PRESSURE SPOTS ARE NOT DEVELOPING. YOU SHOULD REGULARLY CHECK FOR SKIN REDNESS. THE CLINICAL INDICATOR FOR TISSUE BREAKDOWN IS SKIN REDNESS. IF YOUR SKIN DEVELOPS REDNESS, DISCONTINUE THE USE OF THE CUSHION IMMEDIATELY AND SEE YOUR DOCTOR OR THERAPIST." JAY J2 DEEP CONTOUR CUSHION OWNER'S MANUAL REV. D, PAGE 2 STATES: "WARNING! YOUR JAY CUSHION IS DESIGNED TO HELP REDUCE PRESSURE. HOWEVER, NO CUSHION CAN COMPLETELY ELIMINATE SITTING PRESSURE OR PREVENT PRESSURE SORES. THE JAY CUSHION IS NOT A SUBSTITUTE FOR GOOD SKIN CARE INCLUDING, PROPER DIET, CLEANLINESS, AND REGULAR PRESSURE RELIEF." DISCUSSION: IN REVIEWING THE COMPLAINT, THE DEALER REPORTS THAT THEY NOTICED AIR WAS IN THE FLUID BLADDER WHEN THE END USER CAME IN FOR AN EVALUATION. THE DEALER FURTHER REPORTS THERE WAS NOTHING ABNORMAL WHEN THEY RELEASED THE CUSHION TO THE END USER UPON INITIAL INSPECTION. THERE WAS NO ADDITIONAL INFORMATION PROVIDED ON THE CONDITION OF THE CUSHION. A DHR REVIEW FOR THIS PRODUCT WAS CONDUCTED AND NO ABNORMALITIES, DEVIATIONS OR NCMR'S RELATED TO THE CLAIM WERE IDENTIFIED IN THE MANUFACTURING PROCESS. THE JAY2 DC CUSHION WAS MADE TO SPECIFICATION. ACCORDING TO THE DEALER, THE END USER HAS ALLEGEDLY DEVELOPED A STAGE 3 PRESSURE SACRUM WOUND. THERE WAS NO INFORMATION PROVIDED ON CHARACTERISTICS OF THE WOUND OR CURRENT MEDICAL TREATMENT FOR THE END USER. CONCLUSION: IN CONCLUSION, DUE TO THE ALLEGATIONS OF A SERIOUS INJURY (STAGE 3 PRESSURE WOUND), THIS MDR IS BEING FILED.

Description of Event or Problem

DEALER REPORTS THAT THEY NOTICED AIR IN THE FLUID BLADDER WHEN THE END USER CAME IN FOR AN EVALUATION. DEALER PROVIDES THAT THE END USER HAS ALLEGEDLY DEVELOPED A STAGE 3 PRESSURE SACRUM WOUND. THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS.