BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 23590702 · Received November 19, 2025

    Report

    Report Number
    3003442380-2025-16222
    Event Type
    Injury
    Date Received
    November 19, 2025
    Date of Event
    October 12, 2025
    Report Date
    November 14, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. H11: INVESTIGATION SUMMARY. COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6013093 IN QUESTION WAS MANUFACTURED AT THE OSTED SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 14-NOV-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL "6013093". THE COUNT OF COMPLAINT IS 1 WHICH IS BELOW 3 SO NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6013093 WAS MANUFACTURED ACCORDING TO WORK INSTRUCTION (WI) BATCHCARD FOR PRODUCTION OF PACKAGING ROOM ON 28-MAY-2025, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. STERILIZATION REPORT NO. (B)(4) WAS REVIEWED, AND NO DEVIATIONS WERE IDENTIFIED. CLINICAL DATA FROM A PHASE 3 TRIAL INVOLVING SUBCUTANEOUS ADMINISTRATION OF FOSLEVODOPA-FOSCARBIDOPA (PRODUODOPA) INDICATE THAT PATIENTS' MAY EXPERIENCE SIDE EFFECTS PRIMARILY AT THE INFUSION SITE. REPORTED EVENTS INCLUDE ERYTHEMA, PAIN, CELLULITIS, AND OEDEMA. IN SOME CASES, INFUSION SITE INFECTIONS HAVE BEEN OBSERVED, WITH TREATMENT INVOLVING ORAL ANTIBIOTICS. TEST RESULTS: NO SAMPLE WAS PROVIDED. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, NO TREND IDENTIFIED, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SWELLING, REDNESS, AND PAIN IN THE ABDOMEN AFTER REMOVAL OF THE CANNULA ON (B)(6) 2025. THE PATIENT WAS PLACED ON ANTIBIOTICS, AND THE CANNULA SIZE WAS CHANGED BY THE MEDICAL DOCTOR (MD) FROM 6MM TO 9MM. IT WAS ALSO REPORTED THAT A SMALL PIECE OF THE CANNULA WAS STUCK INSIDE THE ABDOMEN, WHICH WAS REMOVED WITH TWEEZERS. THE PATIENT EXPERIENCED INFUSION SITE REACTIONS ONE WEEK AFTER STARTING VYALEV WITH INITIALLY FLUID UNDER THE CANNULA. AFTER CANNULA REMOVAL, THE SITE BECAME HARD AND RED WITHIN A DAY AND WAS PRESCRIBED DOXYCYCLINE AND AMOXICILLIN FROM A FAMILY DOCTOR. THE NEXT DAY, THE REDNESS AT THE INFUSION SITE INCREASED TO ABOUT 6 TO 7 INCHES IN LENGTH AND 5 INCHES IN WIDTH, AND THE AREA BECAME PAINFUL. THE PATIENT THEN VISITED EMERGENCY ROOM WHERE AMOXICILLIN WAS DISCONTINUED, AND A PAIN SHOT WAS ADMINISTERED NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2873397 UNKNOWN UNKNOWN FPA UNOMEDICAL DEVICES S.A. DE C.V. UNKNOWN 6013093

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male