BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL SRS

    MDR report key: 1413832 · Received July 10, 2009

    Report

    Report Number
    2522801-2009-00018
    Event Type
    Other
    Date Received
    July 10, 2009
    Date of Event
    June 2, 2009
    Report Date
    July 9, 2009
    Manufacturer
    SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH)
    Product Code
    NEW
    PMA / PMN Number
    K051609
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN ADDITION TO THE REPORTED PDO MATERIAL, ONE (1) OTHER QUILL SRS PRODUCT WAS ALSO REPORTED. THE OTHER REPORTED PRODUCT MATERIAL WAS REPORTED AS 2-0 MONODERM MATERIAL. INFORMATION IS AS FOLLOWS: MONODERM MATERIAL - MODEL/CATALOG #: YA-1022QMS, LOT #: M513620, EXPIRATION DATE: 10/31/2010, DEVICE MANUFACTURE DATE: 10/2008, 510 (K) #: K072028. THE RETURNED SAMPLE WAS RECEIVED AND IS CURRENTLY UNDERGOING RE-STERILIZATION. UPON RETURN FROM THE STERILIZER, THE SAMPLE WILL BE EVALUATED AND A FOLLOW-UP REPORT WILL BE COMPLETED. THE DEVICE USED IN THIS PROCEDURE WAS RETURNED AND IS CURRENTLY UNDERGOING A RE-STERILIZATION PROCESS. UPON RETURN FROM THE STERILIZER, THE SAMPLE WILL BE EVALUATED AND A FOLLOW-UP REPORT WILL BE COMPLETED. RESULTS/CONCLUSION: THE RESULTS OF THE SAMPLE EVALUATION WILL BE INCLUDED IN THE FOLLOW-UP REPORT. FURTHERMORE, AS DESCRIBED, OVERTIGHTENING OF THE SUTURE AT THE ABDOMINAL DONOR SITE MAY HAVE CONTRIBUTED TO THE NECROSIS. RELEVANT PORTIONS OF THE DEVICE HISTORY RECORDS WERE REVIEWED. NO PERTINENT FINDINGS WERE NOTED. (B) (4).

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT ON (1) OF HIS PATIENTS UNDERWENT A DIEP FLAP PROCEDURE ON (B) (6)-2009. PRODUCTS USED WERE QUILL SRS #2 PDO AND 2-O MONODERM. SINCE THE INITIAL PROCEDURE, THE PATIENT HAS HAD TO UNDERGO FIVE (5) DEBRIDEMENT PROCEDURES TO REMOVE NECROTIC TISSUE AT THE ABDOMINAL INCISION SITE. THE SURGEON ALSO STATES THAT THE PATIENT EXPERIENCED WOUND DEHISCENCE AND INFECTION AS WELL AS THE NECROSIS. THE SURGEON REMOVED BROKEN FRAGMENTS OF SUTURE MATERIAL THAT HAD NOT ABSORBED. THE PATIENT WAS ADMINISTERED ANTIBIOTICS (CEPHALEXIN) TO BE TAKEN FOR EIGHT (8) DAYS. NOTE- OVERTIGHTENING OF THE SUTURE AT THE ABDOMINAL DONOR SITE MAY HAVE CONTRIBUTED TO THE NECROSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUILL SRS BARBED SUTURE WITH NEEDLE NEW SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH) RA-1034Q M298250

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NONE MADE AVAILABLE.