BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 23036683 · Received September 12, 2025

    Report

    Report Number
    2210968-2025-10400
    Event Type
    Injury
    Date Received
    September 12, 2025
    Date of Event
    August 2, 2025
    Report Date
    September 12, 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
    IT
    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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: AM J CASE REP. 2025 AUG 2;26:E947860. DOI: 10.12659/AJCR.947860. PMID: 40751305; PMCID: PMC12327152. HTTPS://DOI.ORG/10.12659/AJCR.947860.

    Description of Event or Problem · 0

    ADVANCED STRATEGIES FOR MANAGING PLEUROPERITONEAL COMMUNICATION IN PERITONEAL DIALYSIS PATIENTS: REPORT OF TWO CASES. THE 2 CASE REPORT OF PPC MANAGED AT THE CENTER, HIGHLIGHTING THE ROLE OF ADVANCED DIAGNOSTIC AND THERAPEUTIC STRATEGIES. BOTH CASES WERE DIAGNOSED VIA PERITONEAL SCINTIGRAPHY USING 99MTC-LABELED ALBUMIN AND CONFIRMED WITH COMPUTED TOMOGRAPHY (CT). THE FIRST CASE, A FEMALE PATIENT, TRANSITIONED TO EXTRACORPOREAL DIALYSIS FOLLOWING DIAGNOSIS. THE SECOND CASE, A MALE PATIENT, INITIALLY UNDERWENT CONSERVATIVE MANAGEMENT WITH A VERY-LOW-PROTEIN DIET FOR 45 DAYS. THIS APPROACH INCLUDED DEFECT CLOSURE WITH PROLENE® SUTURES (ETHICON) AND FIBRIN GLUE APPLICATION AND METAL CLIPS (FROM UNKNOWN MANUFACTURER). REPORTED COMPLICATIONS: HAD PERITONEAL FLUID LEAKAGE (N=?). TREATMENT: OPTED FOR TRANSITION TO EXTRACORPOREAL DIALYSIS. IN ADDITION TO IMAGING, UNDERWENT A THOROUGH EVALUATION OF NUTRITIONAL STATUS AND RESIDUAL RENAL FUNCTION TO OPTIMIZE NUTRITIONAL MANAGEMENT AND THE DIALYSIS PROTOCOL. IN CONCLUSIONS, THE FINDINGS EMPHASIZE THE IMPORTANCE OF EARLY DIAGNOSIS USING ADVANCED IMAGING, TAILORED NUTRITIONAL THERAPY TO BRIDGE TREATMENT, AND MINIMALLY INVASIVE SURGICAL TECHNIQUES TO PRESERVE PD AND RENAL FUNCTION. PERITONEAL SCINTIGRAPHY OFFERS HIGH PRECISION IN MAPPING THE ANATOMICAL DEFECT, FACILITATING TARGETED SURGICAL INTERVENTION VATS. COMBINED WITH PREOPERATIVE IMAGING, IT PROVED TO BE A PRECISE AND EFFECTIVE INTERVENTION. DIETARY INTERVENTION SUCCESSFULLY PREVENTED THE TRANSITION TO EXTRACORPOREAL DIALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2192470 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention