BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DR FOG TREATED SPONGE, STERILE (40 EACH/ BOX)

    MDR report key: 18409300 · Received December 28, 2023

    Report

    Report Number
    1836161-2023-00048
    Event Type
    Malfunction
    Date Received
    December 28, 2023
    Date of Event
    December 4, 2023
    Report Date
    December 4, 2023
    Manufacturer
    ASPEN SURGICAL PRODUCTS, CALEDONIA
    Product Code
    OCT
    PMA / PMN Number
    K932449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ASPEN SURGICAL RECEIVED A REPORT FROM THE DISTRIBUTOR INDICATING THAT PRODUCT WAS FOUND WITH SEAL ISSUES. THE ACTUAL DEVICES WERE NOT RETURNED FOR EVALUATION. THE MANUFACTURING LOT NUMBERS WERE PROVIDED FOR REVIEW. PHOTOGRAPHIC EVIDENCE WAS PROVIDED FOR REVIEW AS WELL. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. H3 OTHER TEXT : DEVICE NOT AVAILABLE.

    Description of Event or Problem · 0

    ASPEN SURGICAL RECEIVED A REPORT FROM THE DISTRIBUTOR INDICATING THAT TWO DOCTOR FOG SPONGES WERE DISCOVERED WITH SEALING ISSUES. THE ITEMS WERE NOT IN USE. NO INJURY/DEATH WAS REPORTED. CUSTOMER REPORTED THE ISSUE FOR MULTIPLE LOT NUMBERS. LOT NUMBER AND RESPECTIVE COMPLAINT NUMBERS ARE AS FOLLOWS: (B)(4), (LOT 353085), (B)(4), (LOT 355685).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1529802 DR FOG TREATED SPONGE, STERILE (40 EACH/ BOX) ANTI-FOG OCT ASPEN SURGICAL PRODUCTS, CALEDONIA DF-3120 353085, 355685

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown