JAY

Additional Manufacturer Narrative

DISCUSSION: IN REVIEWING THE COMPLAINT, THE STATE INSTITUTE FOR DRUG CONTROL (SUKL) IN THE CZECH REPUBLIC WAS NOTIFIED OF A SUSPECTED HEALTH HAZARD FOR THE JAY X'TREME ACTIVE CUSHION, AND AN INVESTIGATION HAS BEEN OPENED. THE INFORMATION PROVIDED BY THE SUKL STATES THAT THE END USER HAD BEEN USING THE CUSHION SINCE NOVEMBER 2023. ACCORDING TO THE NOTIFICATION, AFTER TEN (10) MONTHS OF USE, THE END USER ALLEGEDLY DEVELOPED LARGE PRESSURE SORES THAT REQUIRED PAINFUL TREATMENT. THERE HAS BEEN NO INFORMATION PROVIDED ON WHAT INCIDENT OR SITUATIONS LED TO THE DEVELOPMENT OF THE ALLEGED PRESSURE SORES. THERE HAS BEEN NO INFORMATION PROVIDED ON THE STAGING OF THE PRESSURE SORES OR WHAT TYPE OF TREATMENT IS BEING PERFORMED. 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 END USER HAS NOT RESPONDED TO ANY REQUESTS FOR THE CUSHION TO BE SENT BACK FOR EVALUATION. PER THE REPORT, THE END USER HAS GIVEN SUKL ALL INFORMATION AND HANDED THE MATTER OVER TO HIS LAWYERS. THERE HAS BEEN NO FURTHER DETAILS PROVIDED AT THE TIME OF THIS MDR. CONCLUSION: IN CONCLUSION, DUE TO THE ALLEGATIONS OF SERIOUS INJURIES (LARGE PRESSURE SORES THAT REQUIRE MEDICAL INTERVENTION), THIS MDR IS BEING FILED.

Description of Event or Problem

THE STATE INSTITUTE FOR DRUG CONTROL (SUKL) IN THE CZECH REPUBLIC WAS NOTIFIED OF A SUSPECTED HEALTH HAZARD FOR THE JAY X'TREME ACTIVE CUSHION, AND AN INVESTIGATION HAS BEEN OPENED. THE INFORMATION PROVIDED BY THE SUKL STATES THAT THE END USER HAD BEEN USING THE CUSHION SINCE (B)(6) 2023. ACCORDING TO THE NOTIFICATION, AFTER TEN (10) MONTHS OF USE, THE END USER ALLEGEDLY DEVELOPED LARGE PRESSURE SORES THAT REQUIRED PAINFUL TREATMENT. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED. PER THE REPORT, THE END USER HAS GIVEN SUKL ALL INFORMATION AND HANDED THE MATTER OVER TO HIS LAWYERS.