BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL SRS

    MDR report key: 1449678 · Received August 24, 2009

    Report

    Report Number
    2522801-2009-00022
    Event Type
    Other
    Date Received
    August 24, 2009
    Date of Event
    July 27, 2009
    Report Date
    August 24, 2009
    Manufacturer
    SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)
    Product Code
    NEW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ITEM AND LOT NUMBER FOR THE PRODUCT USED BY THIS PHYSICIAN WAS NOT DISCLOSED. THERE WERE NO SAMPLES RETURNED FOR EVAL. METHOD: THE DEVICE WAS NOT RETURNED FOR EVAL. FURTHERMORE, THE MODEL NUMBER, LOT NUMBER AND TYPE OR SIZE OF MATERIAL USED ARE UNK. FURTHERMORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED WITHOUT THE ITEM/LOT CODE INFO. RESULTS: THE DEVICE WAS NOT RETURNED FOR EVAL. NO PRODUCT EVAL CAN BE PERFORMED. THE TYPE OF QUILL SRS MATERIAL WAS NOT DISCLOSED. ALL MATERIAL TYPES AND 510K NUMBERS ARE AS FOLLOWS: PDO - SIZE 2, 0 AND 2-0 - K051609; PDO - 3-0 AND 4-0 - K071989; PDO - 3-0 HIGH DENSITY - K080680; PDO - 4-0 HIGH DENSITY - K080985; PPN - K052373; MONODERM - K072028; NYLON - K052900. (B)(4) - UNK ITEM NUMBER, QUILL SRS, SIZE UNK, MATERIAL TYPE UNK.

    Description of Event or Problem · 1

    AN UNK SIZED QUILL PRODUCT WAS USED IN AN ORTHOPEDIC CASE TO CLOSE THE RETINACULAR LAYER. THE SURGEON STATED THAT THE PT EXPERIENCED WOUND DEHISCENCE AND HAD TO HAVE AN ADDITIONAL SURGICAL PROCEDURE FOR CLOSURE. MD POSTED THIS ON A SURGEON TO SURGEON WEBSITE, BUT DID NOT REPORT THIS TO ANGIOTECH. MD STATED THAT HE WAS EXPRESSING HIS OPINION REGARDING THE PRODUCT NOT FILING AN OFFICIAL COMPLAINT.

    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.