BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL SRS

    MDR report key: 1031475 · Received April 18, 2008

    Report

    Report Number
    2522801-2008-00013
    Event Type
    Other
    Date Received
    April 18, 2008
    Date of Event
    December 1, 2007
    Report Date
    April 18, 2008
    Manufacturer
    SURGICAL SPECIALTIES (DBA ANGIOTECH)
    Product Code
    NEW
    PMA / PMN Number
    K051609
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE EVENT TO AN ANGIOTECH SALES REPRESENTATIVE ("COMPANY REPRESENTATIVE") WHO IN TURN REPORTED THE EVENT TO THE READING FACILITY COMPLAINT FUNCTION. THE PRODUCT PART NUMBER AND LOT NUMBER ARE UNKNOWN. HOWEVER, THE CUSTOMER REPORTED THE PRODUCT TYPE AS "2-0 PDO" QUILL. THE DEVICE WAS NOT RETURNED FOR EVALUATION. FURTHERMORE, THE PRODUCT PART NUMBER AND LOT NUMBER ARE UNKNOWN. THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO PRODUCT EVALUATION CAN BE PERFORMED.

    Description of Event or Problem · 1

    THE PHYSICIAN STATED THAT SOME PATIENTS HAVE EXPERIENCED GRANULOMA FORMATION ALONG THEIR INCISION LINE APPROXIMATELY THREE (3) MONTHS POSTOPERATIVELY. SURGICAL REMOVAL OF THE SUTURE WAS COMPLETED FOR SEVERAL OF THE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUILL SRS QUILL SRS NEW SURGICAL SPECIALTIES (DBA ANGIOTECH) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention