BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVEAID

    MDR report key: 21599818 · Received March 13, 2025

    Report

    Report Number
    2183634-2025-00001
    Event Type
    Injury
    Date Received
    March 13, 2025
    Date of Event
    May 13, 2023
    Report Date
    February 18, 2025
    Manufacturer
    ALTIMATE MEDICAL, INC.
    Product Code
    INN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ALTIMATE MEDICAL REPLIED TO THE CLAIMS ASSOCIATE AFTER RECEIVING THE INITIAL EMAIL, TO ASK FOR THE SERIAL NUMBER OF THE PRODUCT OR THE SALES ORDER OR THE INVOICE ASSOCIATED WITH THE TRANSATION. THE CLAIMS ASSOCIATE PROVIDED ALTIMATE MEDICAL A COPY OF THE PURCHASE ORDER FOR THE TRANSACTION. FROM THE PROVIDED PO ALTIMATE MEDICAL WAS ABLE TO DETERMINE THE SERIAL NUMBER OF THE DEVICE ((B)(6)) AND THAT THE ACTIVEAID 202 SHIPPED TO THE SAYERVILLE NJ NUMOTION LOCATION ON AUGUST 1, 2019. ALTIMATE ASKED THE CLAIMS ASSOCIATE TO PROVIDE INFORMATION ABOUT THE ALLEGED ISSUE. ALTIMATE MEDICAL ALSO CONDUCTED AN INITIAL RECORDS SEARCH AND DID NOT FIND ANY RECORD INDICATING THAT THE COMPANY HAD BEEN MADE AWARE OF AN ISSUE FOR THAT DEVICE PREVIOUSLY. AFTER SEVERAL DAYS, ALTIMATE MEDICAL FOLLOWED UP WITH THE CLAIMS ASSOCIATED AGAIN REQUESTING INFORMATION REGARDING THE ALLEGED ISSUE. THE CLAIMS ASSOCIATE SHARED WITH ALTIMATE MEDICAL THE DEMAND LETTER DATED JUNE 3, 2024, FROM THE PACKET OF INFORMATION RECEIVED, WHICH PROVIDED SOME DETAIL REGARDING THE ISSUE. THE DEMAND LETTER OUTLINED THAT WHILE ATTEMPTING TO SHOWER ON (B)(6) 2023, THE USER (A PARAPLEGIC) WAS WASHING HIS RIGHT LEG WHILE IN THE SHOWER CHAIR. AFTER HE WASHED HIS RIGHT LEG, HE SAT BACK UP AND THE CHAIR TIPPED FORWARD. DURING THIS MOTION THE CHAIR CRACKED, CAUSING INJURIES TO THE USER. THE USER'S MOTHER DROVE HIM TO THE HOSPITAL. THE USER SUSTAINED A FRACTURE TO HIS RIGHT LEG (FEMUR) AND UNDERWENT SURGERY WHICH REQUIRED PLACING A METAL ROD AND SCREWS IN HIS LEG. HE SPENT APPROXIMATELY 4-5 DAYS IN THE HOSPITAL. AT THE TIME OF THIS FILING, ALTIMATE MEDICAL HAS NOT YET SEEN PICTURES OF THE DEVICE OR BEEN ABLE TO GATHER ADDITIONAL INFORMATION FROM THE USER REGARDING THE EVENT BEYOND WHAT WAS IN THE CLAIM LETTER.

    Description of Event or Problem · 0

    ON 2/18/2025 ALTIMATE MEDICAL, INC. RECEIVED AN EMAIL FROM A CLAIMS ASSOCIATE WITH MEDMARC (WHO PROVIDES NUMOTION WITH THEIR PRODUCTS/COMPLETED OPERATIONS LIABILITY INSURANCE). THEY WERE WRITING TO INFORM ALTIMATE THAT NUMOTION PLACED THEM ON NOTICE OF A CLAIM REGARDING AN ACTIVEAID 202 BATH COMMODE THAT OCCURRED ON MAY 15, 2023. AFTER IDENTIFYING THAT ALTIMATE WAS THE MANUFACTURER OF THE DEVICE, THEY BELIEVED IT WAS NECESSARY TO FORMALLY NOTIFIY ALTIMATE OF THE CLAIM AND REQUESTED ATTENTION TO RESOLVE THE MATTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2143938 ACTIVEAID SHOWER/COMMODE CHAIR INN ALTIMATE MEDICAL, INC. 202

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Disability