BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAY FLUID PAD

    MDR report key: 12321874 · Received August 13, 2021

    Report

    Report Number
    9616084-2021-00049
    Event Type
    Injury
    Date Received
    August 13, 2021
    Date of Event
    November 3, 2020
    Report Date
    August 13, 2021
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Product Code
    KNN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BACKGROUND INFORMATION: SUNRISE CUSHIONS HAVE VARIOUS TYPES OF FILLS (E.G., AIR, FLUID, GEL, FOAM). A COMMON COMPLAINT (MALFUNCTION) IS THE PRESENCE OF AIR IN THE FLUID AND/OR GEL CUSHIONS. WHILE THIS IS CONSIDERED A MALFUNCTION, TO BE CLEAR, THERE IS NO INCREASED LIKELIHOOD OF INJURY DUE TO THE PRESENCE OF AIR IN THE FLUID AND/OR GEL CUSHIONS. AIR IS ALSO CONSIDERED AN ACCEPTABLE CUSHIONING AGENT THAT HELPS TO PREVENT PRESSURE SORES IF USED APPROPRIATELY ALONG WITH PRESSURE RELIEF AND PROPER SKIN MONITORING AND MAINTENANCE. NO CUSHION WILL PREVENT PRESSURE SORES WITHOUT THE COOPERATION AND ACTIVE INVOLVEMENT OF THE USER AND/OR CAREGIVERS. SUNRISE PRODUCTS THAT ARE ORDERED WITH CUSHIONS, ARE PROVIDED CUSHIONS PER DEALER/PROVIDER SPECIFICATIONS. THERE ARE NUMEROUS CUSHION CONFIGURATIONS; SOME ARE DESIGNED FOR INDIVIDUALS MORE PRONE TO DEVELOPING PRESSURE SORES AND SOME ARE NOT. THE DETERMINATION OF WHETHER OR WHICH CUSHION IS NEEDED IS THE DEALER/PROVIDER RESPONSIBILITY TO SPECIFY AS SOME USERS MAY BE DETERMINED, BY A MOBILITY SPECIALIST, TO NEED SPECIFIC CUSHION TYPES (FLUID, GEL, FOAM, ETC.). THIS REQUIREMENT CANNOT BE DETERMINED BY SUNRISE MEDICAL AS WE DO NOT KNOW THE CONDITION OF THE END USER, NOR THE SPECIFIC NEEDS OF THEIR DISABILITY. WHEN SPECIFIC CUSHIONS ARE PROVIDED, PER DEALER REQUIREMENTS, THE EXPECTATION IS THE CUSHION WILL BE FREE OF MANUFACTURING DEFECTS AND WILL PERFORM IN ACCORDANCE WITH ALL WRITTEN MATERIALS (WEBSITE, OWNER MANUAL, ETC.). WHEN CUSHIONS DO NOT PERFORM AS INTENDED, IT IS CONSIDERED A MALFUNCTION OF THE DEVICE AND PRESSURE SORES, WHETHER A SERIOUS INJURY OR NOT, HAVE THE POTENTIAL FOR BECOMING A SERIOUS INJURY. THEREFORE, MOST MALFUNCTIONS OF WHEELCHAIR CUSHIONS ARE CONSIDERED REPORTABLE EVENTS. DISCUSSION: THE CUSHION AT THE TIME OF THE COMPLAINT WAS 1 MONTH OF AGE. THE LIFETIME OF A WHEELCHAIR CUSHION IS 2 YEARS. THEREFORE, THIS CUSHION HAD NOT YET REACHED ITS EFFECTIVE LIFETIME. THE PRESENCE OF HARDENING OR HARD LUMPS IN THE FLUID PAD IS CONSIDERED A MALFUNCTION. CONCLUSION: DUE TO THE MALFUNCTION OF THE CUSHION AND THE REPORT OF AN INJURY REQUIRING MEDICAL INTERVENTION, THIS IS CLASSIFIED AS A SERIOUS INJURY. THEREFORE, AN MDR IS BEING FILED. ADDITIONAL INFORMATION: THIS COMPLAINT HAS BEEN RE-REVIEWED AS A PART OF A FOUR-YEAR RETROSPECTIVE REVIEW AND REMEDIATION EFFORT BASED ON ENHANCEMENTS MADE TO THE COMPANY'S COMPLAINT HANDLING AND ADVERSE EVENT REPORTING PROCESSES. A LEGAL CONSULTING FIRM WAS CONSULTED FOR THE RETROSPECTIVE REVIEW. THIS MDR IS BEING FILED BASED ON THE OUTCOME OF THAT RETROSPECTIVE REVIEW.

    Description of Event or Problem · 1

    CLIENT IS STATING THAT GEL DOES NOT PUSH DOWN AND FORMS A SOLID BALL THAT IS HARD. PER DEALER, THE CLIENT IS STATING THEY ARE IN PAIN AND HAVE HAD TWO DOCTORS' APPOINTMENTS BECAUSE OF THE ISSUE. DIAGNOSTIC AND TREATMENT INFORMATION WAS NOT PROVIDED. NO FURTHER INFORMATION COULD BE OBTAINED REGARDING THIS REPORT. PATIENT CLAIMS TO BE KNEADING GEL, AS PER INSTRUCTIONS, TO PREVENT HARDENING OF GEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1216109 JAY FLUID PAD WHEELCHAIR CUSHION KNN SUNRISE MEDICAL (US) LLC JAY FLUID PAD

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention