BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRANS CHAIR,19", HAMR, 8" WHL, 250 LB

    MDR report key: 23689383 · Received December 1, 2025

    Report

    Report Number
    1417592-2025-00673
    Event Type
    Death
    Date Received
    December 1, 2025
    Date of Event
    August 20, 2025
    Report Date
    May 15, 2026
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    INM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED D9: DEVICE AVAILABLE FOR EVALUATION AND DATE RETURNED TO MANUFACTURER. UPDATED H6: INVESTIGATION FINDINGS (C). UPDATED H6: INVESTIGATION CONCLUSIONS (D).

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE FACILITY, ON (B)(6) 2025, "PATIENT ATTEMPTED TO ROLL OUT ONTO PORCH IN WHEELCHAIR WITHOUT ASSISTANCE. WHEELS WERE NOT PLACED IN THE LOCK POSITION BY CAREGIVER PRIOR TO LEAVING PATIENT ALONE. PATIENT GUIDED HER WHEELCHAIR OVER THE THRESHOLD AND DOWN ONTO THE PORCH WHERE THE WHEELCHAIR FLIPPED OVER. PATIENT SUSTAINED A RIGHT KNEE FRACTURE AND A PELVIC FRACTURE." PER THE FACILITY, "ORTHOPEDIC CONSULT RECOMMENDED SURGERY, BUT PATIENT WAS A POOR CANDIDATE DUE TO COMORBIDITIES. SHE WENT TO REHAB AND THEN RETURNED HOME." FACILITY MENTIONED PATIENT IS NOW DECEASED, HOWEVER UNABLE TO ANSWER WHETHER THE DEVICE CAUSED OR CONTRIBUTED TO THE DEATH. IT IS SUSPECTED THAT THE DEVICE MALFUNCTION CONTRIBUTED TO THE DEATH. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY REQUIRING MEDICAL INTERVENTION, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ACCORDING TO THE FACILITY, ON (B)(6) 2025, "PATIENT ATTEMPTED TO ROLL OUT ONTO PORCH IN WHEELCHAIR WITHOUT ASSISTANCE. WHEELS WERE NOT PLACED IN THE LOCK POSITION BY CAREGIVER PRIOR TO LEAVING PATIENT ALONE. PATIENT GUIDED HER WHEELCHAIR OVER THE THRESHOLD AND DOWN ONTO THE PORCH WHERE THE WHEELCHAIR FLIPPED OVER. PATIENT SUSTAINED A RIGHT KNEE FRACTURE AND A PELVIC FRACTURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28232 TRANS CHAIR,19", HAMR, 8" WHL, 250 LB INM MEDLINE INDUSTRIES, LP 16422050001

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Death| H| O