BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERO CARE CLINER

    MDR report key: 25152822 · Received May 12, 2026

    Report

    Report Number
    1027229-2026-00001
    Event Type
    Injury
    Date Received
    May 12, 2026
    Date of Event
    December 4, 2025
    Report Date
    May 12, 2026
    Manufacturer
    CHAMPION MANUFACTURING, INC.
    Product Code
    INN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH THIS ALLEGED INCIDENT OCCURRED ON (B)(6) 2025 AT THE SITE; THE SITE DID NOT REPORT THIS INFORMATION TO THE MANUFACTURER UNTIL APRIL 13, 2026, BY MAIL. AS THE CASTER FUNCTIONS AS INTENDED, IF THE PERSON PERFORMING THE LIFT ENGAGED THE LOCKING MECHANISM, THE WHEEL COULD NOT HAVE MOVED. THE CASTER WAS REPLACED AT THE SITE AND CONFIRMED THE CHAIR IS FUNCTIONING AS INTENDED, THIS INVESTIGATION IS CLOSED. NO FURTHER ACTIONS.

    Description of Event or Problem · 0

    A COPY OF THE FACILITY'S MEDWATCH FORM 3500A REPORT ARRIVED BY US MAIL ON APRIL 13, 2026. THERE WAS NO REPORT OF THIS INCIDENT TO THE MANUFACTURER PRIOR TO APRIL 13, 2026. THE MEDWATCH REPORT STATES THAT THE PATIENT ARRIVED FOR SCHEDULED DIALYSIS TREATMENT AT THE (B)(6) OUTPATIENT TREATMENT FACILITY. AFTER COMPLETING 5 HOURS OF TREATMENT, WHEN ATTEMPTING TO TRANSFER THE PATIENT TO A WHEELCHAIR WITH 1 ASSIST, THE LOCKED DIALYSIS CHAIR MOVED BACK AND THE PATIENT LOST HIS BALANCE AND FELL ONTO THE FLOOR. THE PATIENT REPORTED RIGHT HIP PAIN. THE REPORT STATES THEY REMAINED ALERT AND THE PATIENT WAS ADMITTED TO THE HOSPITAL AND HAD SURGERY FOR A FRACTURED FEMUR. THE REPORT ALSO STATES THE PATIENT WAS DISCHARGED TO A LOCAL REHABILITATION FACILITY. THIS CHAIR WAS MANUFACTURED ON 5/20/2024 AND SHIPPED TO FRESENIUS ON 5/22/2024. THERE HAVE BEEN NO REPORTED ISSUES OR COMPLAINTS REGARDING THIS CHAIR (SERIAL NUMBER (B)(6) PRIOR TO THE MEDWATCH FORM 3600A RECEIVED ON 4/13/2026. IN ADDITION, THERE IS NO HISTORY OF SERVICE WORK PERFORMED ON (B)(6). REVIEW OF RECORDS CONFIRMED THE CHAIR PASSED ALL INSPECTION CRITERIA. AT THE EVALUATION OF THE CHAIR AT THE SITE, IT APPEARED THAT THE LEFT FRONT CASTER WAS NOT LOCKING INTO PLACE. THE CASTER WAS RETURNED FOR EVALUATION. BASED ON THE REVIEW OF THE PHOTOS FROM THE TECHNICIAN, IT APPEARS THIS CASTER WAS NOT A DIRECTIONAL CASTER, BUT INSTEAD A TOTAL LOCK CASTER. SINCE THE TECHNICIAN WAS EXPECTING A DIRECTIONAL CASTER, HE DID NOT ENGAGE THE LOCKING MECHANISM. UPON EVALUATION OF THE RETURNED CASTER, IT WAS DETERMINED THE LOCKING MECHANISM FUNCTIONS AS INTENDED WHICH PREVENTS THE WHEEL FROM ROTATING AND PREVENTS THE CASTER FROM STEERING. ADDITIONALLY, UPON INSPECTION OF THE CASTER, THE STEM SHOWED IT DOES NOT MATCH THE STANDARD CHAMPION STEM. SINCE THE CASTER FUNCTIONS AS INTENDED, IF THE PERSON PERFORMING THE LIFT ENGAGED THE LOCKING MECHANISM, THE WHEEL COULD NOT HAVE MOVED. THE CASTER WAS REPLACED AT THE SITE AND CONFIRMED THE CHAIR IS FUNCTIONING AS INTENDED, THIS INVESTIGATION IS CLOSED. NO FURTHER ACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591394 VERO CARE CLINER RECLINER CHAIR INN CHAMPION MANUFACTURING, INC. 6X40

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Hospitalization| O