BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL SRS

    MDR report key: 1029615 · Received April 11, 2008

    Report

    Report Number
    2522801-2008-00012
    Event Type
    Other
    Date Received
    April 11, 2008
    Date of Event
    September 19, 2007
    Report Date
    April 11, 2008
    Manufacturer
    SURGICAL SPECIALTIES (DBA ANGIOTECH)
    Product Code
    NEW
    PMA / PMN Number
    K071989
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT INVOLVED IN THIS INCIDENT IS NOT AVAILABLE FOR EVALUATION. RESULTS: CORRESPONDENCE WITH THE DOCTOR THAT PERFORMED THE PROCEDURE IDENTIFIED THAT THE INITIAL CAUSE OF THIS INCIDENT IS MOST LIKELY RELATED TO SUPERFICIAL PLACEMENT OF THE PRODUCT OR USE OF TOO LARGE A SIZE SUTURE, OR BOTH. CONCLUSION: CORRESPONDENCE WITH THE DOCTOR THAT PERFORMED THE PROCEDURE IDENTIFIED THAT THE INITIAL CAUSE OF THE INCIDENT IS MOST LIKELY RELATED TO SUPERFICIAL PLACEMENT OF THE PRODUCT OR USE OF TOO LARGE A SIZE SUTURE, OR BOTH.

    Description of Event or Problem · 1

    THE PATIENT PROVIDED THE FOLLOWING INFORMATION IN 2008: THE PATIENT UNDERWENT AN ABDOMINOPLASTY PROCEDURE APPROXIMATELY SIX (6) MONTHS AGO. HER INCISION HAS NOT HEALED AND CONTINUES TO "OPEN UP" ON THE LEFT SIDE. SHE INITIALLY EXPERIENCED SUTURE SPLITTING AND THEN AREAS OF THE INCISION BEGAN TO "OPEN UP." ACCORDING TO THE PATIENT, HER DOCTOR HAS AGREED TO REVISE THE INCISION BUT IS REQUESTING THAT SHE WAIT UNTIL TEN (10) MONTHS POST OPERATIVELY. CORRESPONDENCE WITH THE DOCTOR THAT PERFORMED THE PROCEDURE IDENTIFIED THAT THE INITIAL CAUSE OF THIS INCIDENT IS MOST LIKELY RELATED TO SUPERFICIAL PLACEMENT OF THE PRODUCT OR USE OF TOO LARGE A SIZE SUTURE OR BOTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUILL SRS QUILL SRS NEW SURGICAL SPECIALTIES (DBA ANGIOTECH) RA-1001Q M100550

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention