BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL SRS

    MDR report key: 1812565 · Received August 12, 2010

    Report

    Report Number
    2522801-2010-00024
    Event Type
    Other
    Date Received
    August 12, 2010
    Date of Event
    July 1, 2010
    Report Date
    August 17, 2010
    Manufacturer
    SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH)
    Product Code
    NEW
    PMA / PMN Number
    K051609
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS EVENT IS ESTIMATED. SAMPLES WERE NOT AVAILABLE FOR EVAL. THE ITEM/LOT CODE INFO WAS NOT PROVIDED. THEREFORE, THE EXP DATE AND MFG DATE ARE UNK. THE PRODUCT INVOLVED IN THIS EVENT WAS REPORTED AS QUILL SRS, 2-0 PDO. A PART/MODEL NUMBER WAS NOT PROVIDED. METHOD: SAMPLES WERE NOT AVAILABLE FOR EVAL. FURTHERMORE, WITHOUT THE ITEM/LOT CODE INFO, RELEVANT PORTIONS OF THE DEVICE HISTORY RECORDS (DHR) AND STERILITY RECORDS COULD NOT BE REVIEWED. RESULTS/CONCLUSIONS: SAMPLES WERE NOT AVAILABLE FOR EVAL. NO PRODUCT EVAL CAN BE PERFORMED. ANGIOTECH REFERENCE: (B)(4), ITEM # UNK, QUILL SRS, 2-0 POD, LOT UNK.

    Description of Event or Problem · 1

    THE DATE OF THE EVENT IS ESTIMATED. A PATIENT REPORTED THAT SHE IS EXPERIENCING A REACTION FOLLOWING A BREAST REDUCTION PROCEDURE PERFORMED BY (B)(6). QUILL SRS 2-0 PDO SUTURE MATERIAL WAS USED FOR DEEP DERMAL LAYER CLOSURE OF THE INFRAMAMMARY INCISION. THE PT ADDED THAT THE REACTION IS CAUSING SEVERE ITCHING AND BURNING ALONG THE INCISION LINES. THE PT HAS BEEN PLACED ON MULTIPLE COURSES OF STEROIDS AS WELL AS ORAL ANTIBIOTICS WITH NO RELIEF OF SYMPTOMS. THE INCISION LINES ARE INTACT AND PATIENT IS HEALING WELL DESPITE THE REACTION. PER (B)(6), THE PATIENT IS REQUESTING TO BE TAKEN BACK TO THE OPERATING ROOM FOR REMOVAL OF THE SUTURE MATERIAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention