BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURACOL PLUS COLLAGEN WOUND DRESSING

    MDR report key: 24903797 · Received April 16, 2026

    Report

    Report Number
    1417592-2026-00469
    Event Type
    Injury
    Date Received
    April 16, 2026
    Date of Event
    March 14, 2026
    Report Date
    April 16, 2026
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    KGN
    PMA / PMN Number
    K060456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER ON (B)(6) 2026, A DRESSING WAS PLACED ON THE HIS RIGHT THIRD TOE STATUS POST AMPUTATION. THE DRESSING WAS REMOVED BY A HOME HEALTH NURSE TWO DAYS LATER, AT WHICH TIME SIGNS OF INFECTION WERE NOTED, INCLUDING FOAMY DRAINAGE FROM THE WOUND AND A FOUL ODOR. THE NURSE ALSO OBSERVED SIGNS OF INFECTION INVOLVING THE FOURTH AND FIFTH TOES OF THE RIGHT FOOT. THE DRESSING WAS CHANGED. THE PODIATRIST WAS NOTIFIED, AND THE PATIENT IS SCHEDULED FOR SURGICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY REQUIRING MEDICAL INTERVENTION, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPDATE TO G4. AFTER FURTHER INVESTIGATION, IT HAS BEEN DETERMINED THAT THE 510(K) NUMBER IS K060456. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER ON (B)(6) 2026, A DRESSING WAS PLACED ON THE HIS RIGHT THIRD TOE STATUS POST AMPUTATION. THE DRESSING WAS REMOVED BY A HOME HEALTH NURSE TWO DAYS LATER, AT WHICH TIME SIGNS OF INFECTION WERE NOTED, INCLUDING FOAMY DRAINAGE FROM THE WOUND AND A FOUL ODOR. THE NURSE ALSO OBSERVED SIGNS OF INFECTION INVOLVING THE FOURTH AND FIFTH TOES OF THE RIGHT FOOT. THE DRESSING WAS CHANGED. THE PODIATRIST WAS NOTIFIED, AND THE PATIENT IS SCHEDULED FOR SURGICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337565 PURACOL PLUS COLLAGEN WOUND DRESSING DRESSING,COLLAGEN,PURACOL PLUS,4.2X4.5" KGN MEDLINE INDUSTRIES, LP

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Other