BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL SRS

    MDR report key: 1395121 · Received March 12, 2009

    Report

    Report Number
    2522801-2009-00005
    Event Type
    Other
    Date Received
    March 12, 2009
    Date of Event
    August 1, 2008
    Report Date
    March 12, 2009
    Manufacturer
    SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)
    Product Code
    NEW
    PMA / PMN Number
    K051609
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT WOULD NOT DIVULGE PHYSICIAN INFO RELEVANT TO THIS EVENT. THE PT DESCRIBED THE PRODUCT AS QUILL SRS PDO. SPECIFIC PRODUCT INFO, SUCH AS THE MODEL NUMBER, LOT NUMBER, ETC., WAS NOT PROVIDED. THE 510(K) NUMBERS FOR ALL QUILL SRS PDO PRODUCTS ARE AS FOLLOWS: K071989, K080680, K080985. METHOD: THE DEVICE WAS NOT RETURNED FOR EVAL. FURTHERMORE, THE MODEL NUMBER AND LOT NUMBER ARE UNK. RESULTS: THE DEVICE WAS NOT RETURNED FOR EVAL. NO PRODUCT EVAL CAN BE PERFORMED. (B)(4). QUILL SRS PDO.

    Description of Event or Problem · 1

    THE PT REPORTED THE FOLLOWING: PT UNDERWENT A NECK SUSPENSION USING QUILL SRS PDO IN (B)(6) 2008. TWO TO THREE WEEKS FOLLOWING THE PROCEDURE, THE PT BEGAN EXPERIENCING REDNESS AND INFLAMMATION ALONG THE SUTURE LINE. THE PT WAS TREATED EMPIRICALLY WITH ORAL ANTIBIOTICS (KEFLEX) AND MONITORED. PAIN, REDNESS AND INFLAMMATION CONTINUED TO WORSEN DESPITE THE USE OF ANTIBIOTICS. THE PT EVENTUALLY HAD THE PRODUCT TAKEN OUT. HOWEVER, SHE STATED THAT THE DOCTOR WAS NOT SURE HOW MUCH OF THE PRODUCT HE WAS ACTUALLY ABLE TO REMOVE. SINCE THE REMOVAL PROCEDURE, THE PT HAS CONTINUED TO HAVE REDNESS AND INFLAMMATION ALONG THE SUTURE LINE. SHE HAS BEEN TREATED WITH MULTIPLE COURSES OF KENALOG AND BOTOX INJECTIONS TO THE NECK IN AN ATTEMPT TO RELEASE SCAR TISSUE WITHOUT SUCCESS. MOST RECENTLY, THE PT HAS BEGUN TO DEVELOP POCKETS OF FLUID BEHIND HER EARS. THIS HAS BEEN CULTURED AND HAS RETURNED POSITIVE FOR STAPH. THE PT CONTINUES TO EXPERIENCE REDNESS AND INFLAMMATION, AS WELL AS PAIN. SHE HAS BEEN ON MULTIPLE COURSES OF ORAL ANTIBIOTICS INCLUDING KEFLEX., TETRACYCLINE, MINACYLCINE, AS WELL AS TOPICAL OINTMENTS, NONE OF WHICH HAVE RELIEVED HER SYMPTOMS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NONE MADE AVAILABLE