BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILK BRD BLK 15X60CM M2.5

    MDR report key: 17749029 · Received September 14, 2023

    Report

    Report Number
    2210968-2023-06687
    Event Type
    Injury
    Date Received
    September 14, 2023
    Date of Event
    July 21, 2023
    Report Date
    October 17, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED . TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE FOLLOWING INFORMATION WAS REQUESTED BUT UNAVAILABLE: PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE. WHAT WAS THE INITIAL APPROACH FOR THE INDEX SURGICAL PROCEDURE? (OPEN, LAPAROSCOPIC OR OTHER)? ON WHAT TISSUE WAS THE SUTURE USED? WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? HOW WAS THE SUTURE PLACED (INTERRUPTED OR CONTINUOUS)? DID THE PATIENT HAVE AN INFECTION? WERE THERE ANY PRE-EXISTING SIGNS/SYMPTOMS OF ACTIVE INFECTION PRIOR TO THIS SURGICAL PROCEDURE? DID THE PATIENT RECEIVE ANY PROPHYLACTIC ANTIBIOTICS PRE-, INTRA- OR POST-OPERATION? WERE CULTURES PERFORMED? IF SO, PLEASE PROVIDE THE RESULTS. HOW MUCH AND WHAT TYPE OF DRAINAGE IS PRESENT IN THIS WOUND? WERE ANY PRE-OP CLEANSING PROCEDURES CHANGED RECENTLY? IF YES, PLEASE DESCRIBE. OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT OR DURING ANY RE-OPERATION? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT'S CURRENT STATUS? LOT NUMBER? CONTACTED WITH THE SALES REP TODAY VIA PHONE, PLEASE REFER TO THE EVENT DESCRIPTION AND OTHER INFORMATION REQUESTED IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT AN APPENDECTOMY ON (B)(6) 2023 AND SUTURE WAS USED. SECRETION. THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO ACUTE SUPPURATIVE APPENDICITIS AND UNDERWENT SURGERY. THE DOCTOR SUTURED THE PATIENT USING A SUTURE. STRICT ASEPTIC PROCEDURES WERE PERFORMED BEFORE AND DURING THE SURGERY. POST-OP, ON THE 5TH MORNING AFTER THE SURGERY, IT WAS FOUND THAT THE PATIENT'S SURGICAL INCISION WAS RED AND SWOLLEN, AND THERE WAS SEEPAGE AND PUS ON THE SKIN OF THE INCISION. THE PATIENT HAD INFLAMMATION AND WOUND SECRETION. PART OF THE SUTURE WAS REMOVED, AND THE SURGICAL INCISION WAS CLEANED WITH HYDROGEN PEROXIDE. STERILE DRESSING AND DRAINAGE WERE PERFORMED. ON THE 9TH DAY AFTER THE SURGERY, IT WAS FOUND THAT THE SURGICAL INCISION WAS NOT RED OR SWOLLEN, AND THERE WAS NO LEAKAGE OR PUS. AFTER CONTINUOUS ASEPTIC DRESSING CHANGE FOR 7 DAYS, THE SURGICAL INCISION HEALED WELL. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2183507 SILK BRD BLK 15X60CM M2.5 SUTURE, NONABSORBABLE, SILK GAP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention