BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 21409573 · Received February 19, 2025

    Report

    Report Number
    2210968-2025-01771
    Event Type
    Injury
    Date Received
    February 19, 2025
    Date of Event
    January 21, 2024
    Report Date
    February 19, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. CITATION: UROLOGY CASE REPORTS 53 (2024) 102663 HTTPS://DOI.ORG/10.1016/J.EUCR.2024.102663.

    Description of Event or Problem · 0

    TITLE: APPLICATION OF THE DIRECT IN-SCOPE SUCTION TECHNIQUE IN ANTEGRADE FLEXIBLE URETEROSCOPIC LITHOTRIPSY FOR THE REMOVAL OF A LARGE URETERIC CALCULUS IN A KIDNEY TRANSPLANT RECIPIENT: A CASE REPORT. THIS IS A CASE STUDY OF A 50-YEAR-OLD FEMALE PATIENT WITH AN IDIOPATHIC ETIOLOGY OF END-STAGE KIDNEY DISEASE UNDERWENT CONTINUOUS AMBULATORY PERITONEAL DIALYSIS RECEIVING FIVE CYCLES DAILY FOR FIVE YEARS. SURGICAL DETAILS INCLUDED AN END-TO-SIDE ANASTOMOSIS OF THE RENAL VEIN TO THE EXTERNAL ILIAC VEIN AND THE RENAL ARTERY TO THE EXTERNAL ILIAC ARTERY USING 6/0 PROLENE RUNNING SUTURES. A 4.8FR DOUBLE-J STENT WAS INSERTED INTO THE URETER, EMPLOYING THE LICH-GREGOIRE TECHNIQUE FOR URETEROVESICAL ANASTOMOSIS WITH INTERRUPTED 5/0 POLYGLYCONATE SUTURES. THE PERCUTANEOUS NEPHROSTOMY TUBE WAS REMOVED 5 DAYS POSTOPERATIVELY, AND THE DOUBLE-J STENT WAS CYSTOSCOPICALLY REMOVED 3 WEEKS POST-DISCHARGE. REPORTED COMPLICATIONS INCLUDED: 6/0 PROLENE SUTURE (ETHICON) A 50-YEAR-OLD FEMALE PATIENT ANURIA AND ABDOMINAL DISCOMFORT (N=1) TREATMENT: MANAGED WITH PERCUTANEOUS NEPHROSTOMY FOR IMMEDIATE ALLEVIATION OF THE URINARY OBSTRUCTION MILD HYDRONEPHROSIS (N=1) TREATMENT: MANAGED WITH PERCUTANEOUS NEPHROSTOMY FOR IMMEDIATE ALLEVIATION OF THE URINARY OBSTRUCTION A 2 CM FILLING DEFECT IN THE MID-URETER (N=1) TREATMENT: TREATED USING FLEXIBLE URETEROSCOPY AND USE THE DISS TECHNIQUE FOR EFFECTIVE STONE REMOVAL IN CONCLUSION, SUCCESSFULLY TREATED A LARGE MID-URETERAL CALCULUS BY APPLYING THE DISS TECHNIQUE IN THE TREATMENT OF LARGE URETERIC CALCULI IN ALLOGRAFT PATIENTS. INTEGRATING A SUCTION SYSTEM NOT ONLY REDUCES THE LIKELIHOOD OF POSTOPERATIVE COMPLICATIONS BUT ALSO IMPROVES VISIBILITY DURING THE PROCEDURE, THEREBY SPEEDING UP THE PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2669988 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention