BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)

    MDR report key: 23943746 · Received January 2, 2026

    Report

    Report Number
    MW5181570
    Event Type
    Malfunction
    Date Received
    January 2, 2026
    Report Date
    November 10, 2025
    Manufacturer
    DIVERSATEK HEALTHCARE, INC.
    Product Code
    FFX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION TO REPLACE THIS NON-(B)(6) DEVICE FOR UNSPECIFIED REASONS. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13955 SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) FFX DIVERSATEK HEALTHCARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other