BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUILL SRS

    MDR report key: 1420102 · Received April 17, 2009

    Report

    Report Number
    2522801-2009-00010
    Event Type
    Malfunction
    Date Received
    April 17, 2009
    Date of Event
    March 1, 2009
    Report Date
    April 17, 2009
    Manufacturer
    SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)
    Product Code
    NEW
    PMA / PMN Number
    K072028
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (6). THE DATE OF EVENT IS ESTIMATED. A SECOND QUILL SRS PRODUCT WAS ALSO REPORTED. THE PRODUCT INFORMATION IS AS FOLLOWS: MODEL CATALOG#: JA-1001Q, LOT#: M352330, EXPIRATION DATE: 03/31/2013, DEVICE MANUFACTURE DATE: 03/2008, 510(K) #: K052373. THE EXPLANT DATE IS ESTIMATED. COMPLAINT PRODUCT HAS BEEN RETURNED AND IS CURRENTLY UNDER EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION. (B) (4), QUILL SRS 2-0 MONODERM, JA-1001Q, QUILL SRS #2 PPN.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A BELT LIPECTOMY PROCEDURE USING QUILL SRS #2 PPN FOR DEEP CLOSURE AND QUILL SRS 2-0 MONODERM, STAPLES AND DERMABOND FOR SUPERFICIAL CLOSURE. THE DOCTOR REPORTED THAT SIX (6) MONTHS FOLLOWING THE PROCEDURE, THE SUTURE HAD NOT DISSOLVED AND THE VERTICAL ASPECT OF THE INCISION LINE KEPT OPENING UP. THE DOCTOR ALSO NOTED BLISTERING ALONG THE INCISION LINE. THE SUTURE WAS SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUILL SRS BARBED SUTURE WITH NEEDLE NEW SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH) YA-1015Q M376460

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention NONE MADE AVAILABLE