BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL SRS

    MDR report key: 1637165 · Received March 19, 2010

    Report

    Report Number
    2522801-2010-00004
    Event Type
    Other
    Date Received
    March 19, 2010
    Date of Event
    December 28, 2009
    Report Date
    March 19, 2010
    Manufacturer
    SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)
    Product Code
    NEW
    PMA / PMN Number
    K051609
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THE EVENT IS ESTIMATED. THE PT RETURNED PIECES OF SUTURE THAT WERE REMOVED FROM HER INCISION BY THE SURGEON. THESE PIECES WERE REVIEWED UNDER A MICROSCOPE. THE MATERIAL WAS CONFIRMED TO BE PDO QUILL SRS. NO OTHER TYPE OF TESTING IS REQUIRED. METHOD: THE RETURNED SAMPLE PIECES WERE RETURNED FOR EVAL AND VISUALLY VIEWED UNDER A MICROSCOPE. RELEVANT PORTIONS OF THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED BECAUSE, THE ITEM AND LOT CODE INFO WAS REPORTED AS "UNK". HOWEVER, AN ORDER HISTORY REPORT FOR (B)(6) HOSPITAL WAS GENERATED TO INCLUDE PAST PURCHASES OF 2-0 AND #2 PDO PRODUCT PURCHASED UP TO SIX (6) MONTHS PRIOR TO RECEIVING THIS NOTIFICATION. NO RELEVANT FINDINGS WERE NOTED FOR ANY OF THESE PURCHASED LOTS. RESULTS/CONCLUSION: INSPECTION CONFIRMED THAT THE MATERIAL WAS QUILL SRS MATERIAL THAT WAS REMOVED FROM THE PT'S INCISION. ACCORDING TO THE SURGEON'S STATEMENT, THE PT IS REACTING TO THE PDO MATERIAL RATHER THAN THE QUILL SRS PRODUCE ITSELF. ANGIOTECH REFERENCE: (B)(4), ITEM # UNK, QUILL SRS, 2-0 PDO, #2 PDO, LOT UNK.

    Description of Event or Problem · 1

    THE DATE OF THIS EVENT IS ESTIMATED. A PT REPORTED THAT SHE UNDERWENT A BILATERAL THIGH LIFT WHERE VICRYL AND QUILL SRS #2 PDO WAS USED FOR DEEP CLOSURE, QUILL SRS 2-O PDO FOR INTERMEDIATE LAYER CLOSURE AND DERMABOND/STERI-STRIPS FOR SKIN CLOSURE. THE PT STATED THAT SHE HAS EXPERIENCED SUTURE SPITTING ALONG ALL INCISION LINES. DURING IN-OFFICE VISITS, THE SURGEON REMOVED QUILL SRS PRODUCT AS IT SURFACED THROUGH THE SKIN. ORAL ANTIBIOTICS WERE GIVEN TO THE PT TO TREAT AN INFLAMMATORY RESPONSE. NO CULTURE AND SENSITIVITIES WERE COMPLETED. THE SURGEON STATED THAT THE REACTION IS RELATED TO THE PDO MATERIAL AND NOT THE QUILL PRODUCT ITSELF. THE PT WAS TAKEN BACK TO THE OPERATING ROOM FOUR (4) MONTHS POST OPERATIVELY FOR REMOVAL OF THE REMAINDER OF QUILL SRS PRODUCT.

    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