BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL KNOTLESS TISSUE CLOSURE DEVICE

    MDR report key: 4847974 · Received June 15, 2015

    Report

    Report Number
    3008845715-2015-00060
    Event Type
    Other
    Date Received
    June 15, 2015
    Report Date
    June 11, 2015
    Manufacturer
    SURGICAL SPECIALTIES PUERTO RICO INC
    Product Code
    NEW
    PMA / PMN Number
    K072028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SECTION THE ACTUAL PROD INVOLVED WITH THE INCIDENT REPORTED IS NOT AVAILABLE AT THIS TIME. PER ELECTRONIC COMMUNICATION FROM THE CUSTOMER IT WAS REPORTED TWO SUSPECT LOTS, MDAD7100 & MQ26150, CLARIFICATION FROM THE CUSTOMER REGARDING LOT NUMBER IS PENDING. HOWEVER, RELEVANT PORTIONS OF THE ABOVE DEVICE HISTORY RECORDS WERE REVIEWED. FINISHED GOOD PROD WERE RECEIVED INTO INVENTORY WITHOUT QUAL ISSUES. THE PROD FROM THESE FINISHED GOOD LOTS AND ALL OF THE COMPONENTS MET SURGICAL SPECIALTIES PUERTO RICO INC REQUIREMENTS THROUGHOUT THE INCOMING, MFG AND THE FINAL INSPECTION PROCESSES. NO INVENTORY AVAILABLE FOR THE SUSPECT FINISHED GOOD LOTS.(B)(4). ITEM YA-2024Q QUILL KNOTLESS TISSUE CLOSURE DEVICE - 2DSM24 2-0 UND MONODERM 30X30, LOT UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED, "WE HAD A YA-2024Q SNAP AND DEHIS IN THEATRES." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388950 QUILL KNOTLESS TISSUE CLOSURE DEVICE BARBED MATERIAL/NEEDLES NEW SURGICAL SPECIALTIES PUERTO RICO INC YA-2024Q UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA NONE MADE AVAILABLE