BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVEAID

    MDR report key: 23796412 · Received December 12, 2025

    Report

    Report Number
    2183634-2025-00002
    Event Type
    Injury
    Date Received
    December 12, 2025
    Date of Event
    November 14, 2025
    Report Date
    November 14, 2025
    Manufacturer
    ALTIMATE MEDICAL, INC.
    Product Code
    INN
    UDI-DI
    1085892100616
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON TUESDAY (B)(6) 2025 THE DIRECTOR OF QUALITY & REGULATORY EMAILED THE THERAPIST WITH MULTIPLE POTENTIAL PRODUCT CONFIGURATION OPTIONS THAT ARE AVAILABLE THAT MAY PROVIDE ADDITIONAL SUPPORT OR SUPPORT THE CLIENT IN A DIFFERENT MANNER. ADDITIONALLY INCLUDED WERE QUESTIONS TO FIND OUT MORE INFORMATION THAT WOULD BE HELPFUL IN REVIEWING AND INVESTIGATING THE ISSUE (SUCH AS HOW THE CLIENT USES THE DEVICE, HOW OFTEN FOR EACH TYPE OF USE, ETC.). ALSO, THAT DAY, THE SALES REPRESENTATIVE SAID THAT HE HAD REACHED OUT TO BOTH THE THERAPIST AND CLIENT DIRECTLY AND HAD NOT YET RECEIVED A RESPONSE. ON FRIDAY (B)(6) 2025 THE DIRECTOR OF QUALITY & REGULATORY RECEIVED AN UPDATE THAT SALES REPRESENTATIVE SAID THAT THE THERAPIST TOLD HIM THAT SHE WOULD GET AHOLD OF HIM IN A FEW WEEKS WHEN THE CLIENT WAS DISCHARGED. ON (B)(6) 2025 THE DIRECTOR OF QUALITY & REGULATORY REACHED OUT TO THE THERAPIST AND SALES REPRESENTATIVE FOR AN UPDATE ON THE CLIENT'S DIAGNOSIS OR ADDITIONAL DETAILS CONCERNING THE ISSUE TO ASSIST IN THE REVIEW OF THE SITUATION. THE THERAPIST WAS OUT OF THE OFFICE THAT DAY PER AN OUT OF OFFICE NOTIFICATION. AT THE TIME OF THIS FILING ON (B)(6) 2025 NO RESPONSE HAS BEEN RECEIVED. DUE TO LIMITED INFORMATION, WE WERE UNABLE TO FULLY ASSESS THE SERIOUSNESS OF THE ALLEGED INJURY.HOWEVER SINCE THE AVAILABLE INFORMATION INDICATES THAT THE PATIENT WAS HOSPITALIZED, WE HAVE DECIDED TO PROCEED WITH FILING AT THIS TIME. PREVIOUS ISSUES/COMPLAINTS LOGGED FOR THE 285TR WERE REVIEWED. THIS IS THE FIRST COMPLAINT RECEIVED FOR THIS DEVICE SERIAL NUMBER A38241011005. THIS IS THE FIRST COMPLAINT REGARDING THE SNAP BUTTON IN THE GOOSENECK LEG REST ASSEMBLY ALLEGEDLY CAUSING AN INJURY (IN THIS CASE A PRESSURE WOUND) AND ALSO THE FIRST COMPLAINT ALLEGEDLY CAUSING AN INJURY (IN THIS CASE A PRESSURE WOUND) FROM CONTACT WITH THE TILT/RECLINE CONTROL BOXES BEHIND THE ADJUSTABLE TENSION SLING BACK. THE GOOSENECK STYLE LEG RESTS WITH THE SNAP BUTTON USED TO ADJUST THE LENGTH OF THE GOOSENECK IS USED ON MULTIPLE PRODUCTS. THERE HAVE BEEN NO COMPLAINTS OF THE SNAP BUTTON CAUSING AN INJURY RELATED TO THE OTHER PRODUCTS. THROUGH 2024, THERE HAD BEEN MORE THAN 858 285TRS DISTRIBUTED SINCE IT'S RELEASE IN 2016 FOR AN ISSUE RATE OF 0.1% FOR THE ISSUES IN THIS CASE. THE CLIENT'S DEVICE IS CONFIGURED WITH A SLING BACK THAT HAS ADJUSTABLE TENSION STRAPS. AT THIS TIME, IT IS BELIEVED THAT THE ADJUSTABLE TENSION STRAPS ON THE SLING BACK WERE ADJUSTED LOOSELY ALLOWING ENOUGH SLACK FOR THE USER TO SINK INTO THE BACK TO THE POINT WHERE THEY COULD CONTACT THE CONTROL BOXES. THE CONTROL BOXES ARE MOUNTED ON THE CROSS-BAR BRACE APPROXIMATELY ~3" BEHIND THE BACK. THE CLIENT'S DEVICE IS CONFIGURED WITH GOOSENECK LEG RESTS, A 2" WIDE CALF STRAP AND HEEL LOOPS ON THE FOOTPLATES. AT THIS TIME, IT IS BELIEVED THAT THE OPTIONS SELECTED FOR THE CLIENT ARE NOT SUFFICIENT FOR THE CLIENT'S NEEDS AND THAT THE DEVICE SHOULD BE CONFIGURED WITH DIFFERENT OPTIONS TO ASSIST IN CONTROLLING THE CLIENT'S POSITIONING OF THEIR LEG TO PREVENT HIS FOOT FROM SLIDING OFF THE FOOTPLATE.

    Description of Event or Problem · 0

    ON NOVEMBER 14, 2025, ALTIMATE MEDICAL, INC. RECEIVED AN EMAIL FROM ONE OF THEIR SALES MANAGERS WHICH WAS FORWARDED TO THEM FROM ONE OF THEIR INDEPENDENT SALES REPRESENTATIVES WHO RECEIVED AN EMAIL WITH THE SUBJECT LINE ACTIVEAID TROUBLESHOOTING FROM AN SCI PHYSICAL THERAPIST WITH (B)(6). THE EMAIL FROM THE THERAPIST READ "I HAVE A PATIENT IN A 2-YEAR-OLD ACTIVE AID CHAIR WHO HAS AN UNSTAGEABLE WOUND ON HIS LEG ALONG WITH WOUNDS ON HIS BACK. IT SEEMS THAT THE LEG WOUND IS FROM THE PIN THAT HOLDS THE LEGREST LENGTH IN PLACE AND THAT THE PATIENT'S LEG OCCASIONALLY COMES OFF THE FOOT PLATE AND SLIDES ALONG THAT PIN. HE ALSO HAS WOUNDS ON HIS BACK FROM THE TILT AND RECLINE BUTTONS, THE PATIENT APPEARS TO HAVE A CLOTH BACKREST AS OPPOSED TO PADDED. THEY'RE OPEN TO YOU STOPPING BY TO SEE IF ANY CHANGES CAN BE MADE TO THE CURRENT CHAIR OR IF WE HAVE TO CONSIDER A DIFFERENT STYLE AND/OR MANUFACTURER." ADDITIONALLY, SHE OUTLINED THAT THE PATIENT GAVE CONSENT TO PROVIDE HIS CONTACT INFOMRATION TO THE SALES REPRESENTATIVE AND THAT HE MAY ALSO BE ADMITTED TO THE HOSPITAL NEXT WEEK IF THEY HAD ANY BEDS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2760244 ACTIVEAID 285TR INN ALTIMATE MEDICAL, INC. 285TR 1085892100616

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization