BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)

    MDR report key: 24817789 · Received April 8, 2026

    Report

    Report Number
    2023374-2026-00001
    Event Type
    Malfunction
    Date Received
    April 8, 2026
    Date of Event
    January 2, 2026
    Report Date
    April 8, 2026
    Manufacturer
    DIVERSATEK HEALTHCARE
    Product Code
    FFX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DIVERSATEK HEALTHCARE ACKNOWLEDGES RECEIPT OF THE FDA MEDWATCH REPORT REFERENCED ABOVE. UPON RECEIPT, THE REPORT WAS EVALUATED IN ACCORDANCE WITH OUR INTERNAL PROCEDURES AND 21 CFR PART 803. THE MEDWATCH REPORT DOES NOT INCLUDE SUFFICIENT INFORMATION TO IDENTIFY THE SPECIFIC DEVICE ALLEGEDLY INVOLVED IN THE REPORTED EVENT. THE REPORT LACKS DEVICE IDENTIFIERS SUCH AS PRODUCT NAME, MODEL NUMBER, CATALOG NUMBER, LOT/SERIAL NUMBER, OR OTHER DISTINGUISHING CHARACTERISTICS THAT WOULD ALLOW DIVERSATEK TO CONFIRM WHETHER ONE OF OUR DEVICES WAS INVOLVED. A REVIEW OF THE INFORMATION PROVIDED WAS CONDUCTED AGAINST OUR ENTIRE PRODUCT PORTFOLIO, ALL OF WHICH ARE CLASSIFIED AS LOW RISK MEDICAL DEVICES AND HAVE A DOCUMENTED HISTORY OF SAFE USE. BASED ON THE INFORMATION AVAILABLE, NO DEVICE SPECIFIC CORRELATION COULD BE ESTABLISHED. REASONABLE FOLLOW UP EFFORTS WERE UNDERTAKEN TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO FURTHER DETAILS WERE AVAILABLE THAT WOULD ENABLE DEVICE IDENTIFICATION OR EVENT VERIFICATION. BASED ON THE ABSENCE OF IDENTIFIABLE DEVICE INFORMATION, WE ARE UNABLE TO DETERMINE WHETHER THE REPORTED EVENT INVOLVED ONE OF OUR DEVICES OR WHETHER THE EVENT MEETS MDR REPORTING CRITERIA. THIS MDR IS THEREFORE CLOSED AS UNABLE TO CONFIRM DEVICE INVOLVEMENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THAT IDENTIFIES A DIVERSATEK HEALTHCARE DEVICE OR PROVIDES FURTHER DETAIL REGARDING THE EVENT, THE COMPLAINT WILL BE PROMPTLY RE EVALUATED AND APPROPRIATE REGULATORY ACTION WILL BE TAKEN, IF NECESSARY.

    Description of Event or Problem · 0

    PER MAUDE ADVERSE EVENT REPORT NUMBER MW5181570: 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). DIVERSATEK HEALTHCARE ACKNOWLEDGES RECEIPT OF THE FDA MEDWATCH REPORT REFERENCED ABOVE. UPON RECEIPT, THE REPORT WAS EVALUATED IN ACCORDANCE WITH OUR INTERNAL PROCEDURES AND 21 CFR PART 803. THE MEDWATCH REPORT DOES NOT INCLUDE SUFFICIENT INFORMATION TO IDENTIFY THE SPECIFIC DEVICE ALLEGEDLY INVOLVED IN THE REPORTED EVENT. THE REPORT LACKS DEVICE IDENTIFIERS SUCH AS PRODUCT NAME, MODEL NUMBER, CATALOG NUMBER, LOT/SERIAL NUMBER, OR OTHER DISTINGUISHING CHARACTERISTICS THAT WOULD ALLOW DIVERSATEK TO CONFIRM WHETHER ONE OF OUR DEVICES WAS INVOLVED. A REVIEW OF THE INFORMATION PROVIDED WAS CONDUCTED AGAINST OUR ENTIRE PRODUCT PORTFOLIO, ALL OF WHICH ARE CLASSIFIED AS LOW-RISK MEDICAL DEVICES AND HAVE A DOCUMENTED HISTORY OF SAFE USE. BASED ON THE INFORMATION AVAILABLE, NO DEVICE SPECIFIC CORRELATION COULD BE ESTABLISHED. REASONABLE FOLLOW UP EFFORTS WERE UNDERTAKEN TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO FURTHER DETAILS WERE AVAILABLE THAT WOULD ENABLE DEVICE IDENTIFICATION OR EVENT VERIFICATION. BASED ON THE ABSENCE OF IDENTIFIABLE DEVICE INFORMATION, WE ARE UNABLE TO DETERMINE WHETHER THE REPORTED EVENT INVOLVED ONE OF OUR DEVICES OR WHETHER THE EVENT MEETS MDR REPORTING CRITERIA. THIS MDR IS THEREFORE CLOSED AS UNABLE TO CONFIRM DEVICE INVOLVEMENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THAT IDENTIFIES A DIVERSATEK HEALTHCARE DEVICE OR PROVIDES FURTHER DETAIL REGARDING THE EVENT, THE COMPLAINT WILL BE PROMPTLY RE EVALUATED AND APPROPRIATE REGULATORY ACTION WILL BE TAKEN, IF NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366629 SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) FFX DIVERSATEK HEALTHCARE UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown