BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUILL

    MDR report key: 18603647 · Received January 29, 2024

    Report

    Report Number
    3010692967-2024-00004
    Event Type
    Injury
    Date Received
    January 29, 2024
    Report Date
    January 25, 2024
    Manufacturer
    SURGICAL SPECIALTIES CORPORATION
    Product Code
    NEW
    PMA / PMN Number
    K080985
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    L#: C118HRG. P/N: RA-1029Q. STARTED DATE: (B)(6) 2022. FIRST OPERATION DATE: (B)(6) 2022. BAR/UDICODE: (B)(4). STERILITY RECORDS CONFIRMED BOTH LOTS MET ALL REQUIREMENTS. NO QUALITY DEFECTS OF THE SUTURE MATERIAL IDENTIFIED. NO ADDITIONAL DETAILS COULD BE OBTAINED REGARDING PROCEDURE, SURGEON''S TECHNIQUE, FACILITY, INFECTION RATE, PATIENT SPECIFICS, POST OPERATIVE EVENTS OR ADHERENCE TO POST-OPERATIVE INSTRUCTIONS.

    Additional Manufacturer Narrative · 0

    RA-1029Q, : C118HRG, C118HRF, EXPIRY: 01/19/2027. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE REPORTED LOTS AND RAW MATERIAL COMPONENTS IDENTIFIED NO QUALITY ISSUES DURING THE INCOMING, MANUFACTURING, IN-PROCESS, STERILITY, OR FINAL INSPECTION PROCESSES. NO OTHER COMPLAINTS WERE REPORTED FOR THE TWO FINISHED GOOD LOTS. NO STERILE DEVICES OR RETAINED SAMPLES WERE AVAILABLE FOR REVIEW/TESTING. IF SAMPLES BECOME AVAILABLE AT A LATER TIME, THEY WILL BE REVIEWED, AND THE RESULTS WILL BE INCLUDED IN THE FILE. A FOLLOW-UP REPORT WILL BE SUBMITTED AT THAT TIME. ADVERSE EFFECTS ASSOCIATED WITH THE USE OF THIS DEVICE MAY INCLUDE, WOUND DEHISCENCE, FAILURE TO PROVIDE ADEQUATE WOUND SUPPORT IN CLOSURE OF THE SITE WHERE EXPANSION, STRETCHING OR DISTENSION OCCUR, FAILURE TO PROVIDE ADEQUATE WOUND SUPPORT IN ELDERLY, MALNOURISHED OR DEBILITATED PATIENTS OR IN PATIENTS SUFFERING FROM CONDITION WHICH MAY DELAY WOUND HEALING, INFECTION, MINIMAL ACUTE INFLAMMATORY TISSUE REACTION, LOCALIZED IRRITATION WHICH SKIN SUTURES ARE LEFT IN PLACE FOR GREATER THAN SEVEN (7) DAYS, SUTURE EXTRUSION AND DELAYED ABSORPTION IN TISSUE WITH POOR BLOOD SUPPLY, CALCULI FORMATION IN URINARY AND BILIARY TRACTS WHEN PROLONGED CONTACT WITH SALT SOLUTIONS SUCH AS URINE AND BILE OCCURS AND TRANSITORY LOCAL INFECTION AT THE WOUND SITE. INFECTIONS, ERYTHEMA, FOREIGN BODY REACTIONS, TRANSIENT INFLAMMATORY REACTIONS AND IN RARE INSTANCES DEHISCENCE ARE TYPICAL OR FORESEEABLE RISKS ASSOCIATED WITH ANY SUTURE AND HENCE ARE ALSO POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE UTILIZED FOR THIS PROCEDURE. WITHOUT RECEIVING STERILE DEVICES FROM THE SAME FINISHED GOOD LOT TO TEST OR RECEIVING DETAILS REGARDING THE PRE-OPERATIVE PREPARATION OF THE DEVICE, PROCEDURES PERFORMED, METHOD UTILIZED TO SECURE THE DEVICE IN THE TISSUE, PATIENT HEALTH STATUS (PAST REACTIONS TO SUTURE MATERIAL, MEDICATIONS, OTHER MEDICAL MATERIALS), QUALITY OF THE TISSUE UTILIZED TO SECURE THE DEVICE, POST-OPERATIVE ACTIVITIES THAT MAY HAVE OCCURRED THAT COULD HAVE AFFECTED THE HEALING OF THE INCISIONS, RESULTS OF CULTURES OR OTHER POST-OPERATIVE TESTING OR DETAILS OF THE FACILITIES/SURGEON'S INFECTION RATE, SURGEON¿S TECHNIQUE, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME.

    Description of Event or Problem · 0

    DR. (B)(6) REPORTED THE PRODUCT CAUSED CELLULITIS/INFECTION IN ALL OPERATED PATIENTS. PHOTOS PROVIDED, NO PATIENT SPECIFICS, DETAILS OF THE PROCEDURES OR FACILITIES INFECTION RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1142360 QUILL 2T9 -0- PDO 14 X 14 NEW SURGICAL SPECIALTIES CORPORATION RA-1029Q C118HRF

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention