BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Absorbable synthetic wound dressing

    MDR report key: 22775501 · Received August 11, 2025

    Report

    Report Number
    3027386220-2025-00001
    Event Type
    Malfunction
    Date Received
    August 11, 2025
    Date of Event
    February 13, 2025
    Report Date
    February 28, 2025
    Manufacturer
    ACERA SURGICAL, INC
    Product Code
    QSZ
    PMA / PMN Number
    K223725
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MALFUNCTION WAS VERIFIED, BUT NO CONCLUSIVE FINDING IS AVAILABLE AND CAUSE WAS NOT ESTABLISHED. THERE WERE NO HEALTH CONSEQUENCES OR IMPACT AS THE UNIT WAS NOT USED ON ANY PATIENT. AFTER INTERNAL INVESTIGATION (B)(4), THIS WAS DEEMED AN ISOLATED INCIDENT LIMITED TO THIS DEVICE, WITH NO OTHER KNOWN UNITS IMPACTED TO DATE.

    Description of Event or Problem · 0

    CUSTOMER CLAIMED THAT UPON OPENING THE FOIL PACKAGING OF DEVICE #0093 FROM LOT 10107 (RESTRATA MINIMATRIX, RMINI-2000), LOOSE PRODUCT WAS FOUND OUTSIDE OF THE INNER STICK-PACK, BUT WITHIN THE FOIL PACKAGING, SUGGESTING THE INNER PACKAGING WAS COMPROMISED. THE DEVICE WAS NOT USED ON ANY PATIENT, AND IT WAS RETURNED TO ACERA FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2035442 Absorbable synthetic wound dressing QSZ N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown