BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL SRS

    MDR report key: 1023559 · Received March 28, 2008

    Report

    Report Number
    2522801-2008-00008
    Event Type
    Other
    Date Received
    March 28, 2008
    Date of Event
    October 25, 2007
    Report Date
    March 28, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT REPORT A SPECIFIC PRODUCT CODE OR LOT NUMBER. HOWEVER, THE FOLLOWING PRODUCT DESCRIPTION WAS PROVIDED BY THE CUSTOMER: QUILL PDO 14X14 2-0. THE DEVICE WAS NOT RETURNED FOR EVAL. FURTHERMORE, THE PRODUCT CODE/LOT NUMBER IS UNK. THE DEVICE WAS NOT RETURNED FOR EVAL. NO PRODUCT EVAL CAN BE PERFORMED.

    Description of Event or Problem · 1

    PT UNDERWENT AN ABDOMINOPLASTY PROCEDURE IN 2007. THE PT HAD WOUND INFLAMMATION ONE WEEK FOLLOWING THE PROCEDURE AND DEVELOPED A LOCALIZED SUTURE ABSCESS. THE DOCTOR WAS ABLE TO MANAGE THE INFLAMMATION AND ABSCESS WITH AN ORAL ANTIBIOTIC THERAPY AND INCISION AND DRAINAGE.

    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