BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL SRS

    MDR report key: 1148555 · Received August 29, 2008

    Report

    Report Number
    2522801-2008-00026
    Event Type
    Other
    Date Received
    August 29, 2008
    Date of Event
    July 1, 2008
    Report Date
    August 29, 2008
    Manufacturer
    SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH)
    Product Code
    NEW
    PMA / PMN Number
    K051609
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SPECIFIC PRODUCT CODE(S)/LOT(S) WERE MADE AVAILABLE. HOWEVER, THIS TYPE OF PRODUCT INVOLVED WITH THE PROCEDURES WAS DESCRIBED AS 2-0 QUILL SRS PDO. METHOD: THE DEVICE WAS NOT RETURNED FOR EVALUATION. RESULTS: THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO PRODUCT EVALUATION CAN BE PERFORMED. FURTHERMORE, THE PRODUCT CODE(S)/LOT(S) ARE UNK. (B) (4).

    Description of Event or Problem · 1

    THE PT UNDERWENT A BREAST REDUCTION WHERE 2-0 QUILL SRS PDO WAS USED FOR THE PROCEDURE. SUBSEQUENTLY, SHE EXPERIENCED SUTURE SPITTING/EXTRUSION & INFLAMMATION AT HER INFRAMAMMARY FOLD AND REQUIRED MEDICAL INTERVENTION TO RESOLVE THE INCIDENT. THE DOCTOR EXAMINED THE PT THREE WEEKS POST SURGERY. SYMPTOMS NOTED AT THE TIME OF THE EXAMINATION WERE PAIN, REDNESS, SWELLING AND CLEAR DRAINAGE AT THE INCISION SITE. EXTRUDED PORTIONS OF THE SUTURE WERE REMOVED AT THIS TIME. A FEW DAYS LATER, THE PT WAS PRESCRIBED AN ORAL ANTIBIOTIC WHILE OUT OF TOWN (NO DOCTOR EXAMINATION PERFORMED). A CULTURE AND SENSITIVITIES TEST WAS NOT PERFORMED. DUE TO INCREASED INFLAMMATION, AT FOUR WEEKS POST SURGERY, LOCAL ANESTHESIA WAS USED TO REMOVE THE REMAINDER OF THE SUTURE. A FOLLOW-UP EXAMINATION FOUR DAYS LATER SHOWED THAT THE PT'S SYMPTOMS HAD CLEARED UP. ADDITIONAL COMMUNICATION WITH THE DOCTOR'S OFFICE/STAFF INDICATES THAT THE SUTURE MAY HAVE BEEN PLACED TOO SUPERFICIALLY DURING THE BREAST REDUCTION PROCEDURE. FURTHERMORE, IT IS NOTED THAT THIS PT UNDERWENT AN ABDOMINOPLASTY AT THE SAME TIME AS THE BREAST REDUCTION PROCEDURE. HOWEVER, THE PT EXPERIENCED NO COMPLICATIONS RELATED TO THE ABDOMINOPLASTY EVEN THOUGH 2-0 QUILL SRS PDO WAS ALSO USED. THE DOCTOR'S OFFICE/STAFF INDICATED THAT THEY RECENTLY CHANGED THEIR PLACEMENT OF QUILL SRS PDO FROM THE SUBCUTICULAR REGION (SUPERFICIAL PLACEMENT) TO THE DEEP DERMIS AND EXPECT TO SEE IMPROVEMENTS WITH THIS NEW APPROACH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NONE MADE AVAILABLE