BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILK SUTURE UNKNOWN PRODUCT

    MDR report key: 18838496 · Received March 5, 2024

    Report

    Report Number
    2210968-2024-02398
    Event Type
    Injury
    Date Received
    March 5, 2024
    Date of Event
    October 20, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2024-02397. CITATION: ITALIAN JOURNAL OF PEDIATRICS, (2023); 49 (142): 1-5.

    Description of Event or Problem · 0

    TITLE: UNNECESSITY OF ROUTINE CHEST TUBE DRAINAGE AFTER PATENT DUCTUS ARTERIOSUS LIGATION IN PRETERM NEONATES. THIS STUDY RETROSPECTIVELY REVIEWED THE MEDICAL RECORDS OF 56 PRETERM NEONATES (29 FEMALES, 27 MALES WITH MEAN AGE OF 26.6 [25.9¿28.8] WEEKS) WHO UNDERWENT SURGICAL LIGATION OF PDA VIA THORACOTOMY IN THE NEONATAL INTENSIVE CARE UNIT BETWEEN JANUARY 2014 AND MARCH 2022. ALL SURGERIES WERE PERFORMED IN THE NEONATAL INTENSIVE CARE UNIT TO AVOID MISHAPS THAT COULD OCCUR DURING THE TRANSPORT OF NEONATES TO THE OPERATING ROOM. ALL PATIENTS WERE UNDER VENTILATOR SUPPORT AND THE OPTIMAL VENTILATOR SETTINGS WERE MANAGED BY A NEONATOLOGIST. THIS STUDY WERE TREATED WITH 4-0 BLACK SILK AND 6-0 SURGIPRO SUTURES AND 7-0 PROLENE SUTURES (ETHICON). THE MEDIAN AGE ON THE DAY OF SURGERY WAS 17.0 (IQR: 10.0¿22.0) DAYS AND THE MEDIAN BODY WEIGHT ON THE DAY OF SURGERY WAS 1100 (IQR: 958¿1410) G. THE MEDIAN OPERATIVE TIME WAS 44.5 (IQR: 35.5¿54.0) MINUTES. THERE WERE NO INTRAOPERATIVE EVENTS OR PROCEDURE-RELATED DEATHS. ON POSTOPERATIVE CHEST RADIOGRAPHS, NO PATIENTS HAD MAJOR COMPLICATIONS, SUCH AS PNEUMOTHORAX OR HEMOTHORAX. NO PATIENTS REQUIRED ADDITIONAL CHEST TUBE DRAINAGE FOR POSTOPERATIVE BLEEDING, PLEURAL EFFUSION, OR PROGRESSIVE SUBCUTANEOUS EMPHYSEMA. NO PATIENTS HAD SURGICAL WOUND INFECTIONS. THE FOLLOWING EVENTS CANNOT BE RULED OUT AS COMPLAINTS: PATIENT INFORMATION (4-0 BLACK SILK, 7-0 PROLENE SUTURE), (N=19) SUBCUTANEOUS EMPHYSEMA: (N=9) SCANTY, (N=6) MILD, (N=4) MODERATE (N=1) RESIDUAL PDA SHUNT, TREATMENT: NO TREATMENT IN CONCLUSION, OMITTING CHEST TUBE DRAINAGE IS FEASIBLE AND SAFE FOR THE POSTOPERATIVE MANAGEMENT OF PRETERM NEONATES UNDERGOING PDA LIGATION VIA THORACOTOMY. A MINOR COMPLICATION WAS SUBCUTANEOUS EMPHYSEMA AROUND THE THORACOTOMY SITE, SPONTANEOUSLY ABSORBED WITHOUT ACTIVE INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138100 SILK SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SILK GAP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other