BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL SRS

    MDR report key: 1023560 · Received March 28, 2008

    Report

    Report Number
    2522801-2008-00007
    Event Type
    Other
    Date Received
    March 28, 2008
    Date of Event
    January 23, 2008
    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

    TWO (2) PRODUCT CODES WERE REPORTED BY THE CUSTOMER. THEY WERE NOT CERTAIN WHICH OF THE TWO PRODUCTS WAS INVOLVED IN THE EVENT. INFO FOR THE SECOND PRODUCT CODE REPORTED IS AS FOLLOWS: MODEL#/CATALOG# RA-1007Q, LOT#: UNK, EXPIRATION DATE: UNK, 510(K)#: K051609. THE DEVICE WAS NOT RETURNED FOR EVAL. FURTHERMORE, THE PRODUCT LOT NUMBER IS UNK. NO PRODUCT EVAL CAN BE PERFORMED.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A MASTOPEXY PROCEDURE IN 2008. THE PATIENT'S INCISION HEALED BUT SHE EXPERIENCED A "TATTOOING" EFFECT NEAR THE SITE OF THE SURGERY. THE PATIENT UNDERWENT SURGICAL REVISION 8 WEEKS POSTOPERATIVELY DUE TO THE "TATTOOING" EFFECT. THE SURGEON REPORTS REMOVING THE SUTURE AND SURROUNDING DISCOLORED TISSUE. THE SURGEON NOTED THAT THE PATIENT'S PALE SKIN WAS MOST LIKELY A FACTOR IN THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUILL SRS QUILL SRS NEW SURGICAL SPECIALTIES (DBA ANGIOTECH) RA-1036Q UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention