BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 22167197 · Received June 9, 2025

    Report

    Report Number
    2210968-2025-06492
    Event Type
    Injury
    Date Received
    June 9, 2025
    Date of Event
    January 1, 2025
    Report Date
    June 9, 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
    MN, US
    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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. CITATION: J PLAST RECONSTR AESTHET SURG. 2025 APR;103:316-323. HTTPS://DOI.ORG/10.1016/J.BJPS.2025.01.046. EPUB 2025 JAN 29. PMID: 40049036.

    Description of Event or Problem · 0

    TITLE: TISSUE EXPANSION AND HETEROLOGOUS MESH FOR ABDOMINAL WALL RECONSTRUCTION IN THE SURGICAL SEPARATION OF CONJOINED TWINS: A CASE SERIES. THIS RETROSPECTIVE STUDY AIMS TO PRESENT AN OVERVIEW OF TISSUE EXPANSION IN THE RECONSTRUCTION AND SURGICAL CLOSURE OF VAST ABDOMINAL WALL DEFECTS AFTER CONJOINED TWIN SEPARATION AND A REPORT OF OUR CLINICAL EXPERIENCE. BETWEEN 1991 AND 2020, A TOTAL OF 4 PAIRS OF CONJOINED TWINS (3 FEMALES, 1 MALE) UNDERWENT ABDOMINAL SEPARATION, WHILE USING 2¿0 VICRYL FOR FASCIA CLOSURE, 3¿0 AND 4¿0 PROLENE FOR APPROXIMATION OF SUBCUTANEOUS TISSUE AND DERMIS, AND 4¿0 MONOCRYL FOR RUNNING SUBCUTICULAR SUTURES FOR SKIN. REPORTED COMPLICATIONS ARE: 2¿0 VICRYL. 3¿0 AND 4¿0 PROLENE. 4¿0 MONOCRYL. CASE 1: PERIUMBILICAL HERNIA N=1. TREATMENT: OBSERVATION. CASE 2: N=1 TWIN A. DELAYED HEALING OF EPIGASTRIUM. TREATMENT: TREATED CONSERVATIVELY. PERIUMBILICAL HERNIA. TREATMENT: OBSERVATION. CASE 3: N=1 TWIN A. DELAYED HEALING OF EPIGASTRIUM. TREATMENT: TREATED CONSERVATIVELY. N=1 TWIN M. IMMEDIATE ABDOMINAL COMPARTMENT SYNDROME. TREATMENT: RECTIFIED WITH REDUCED TENSION CLOSURE. RESPIRATORY INSUFFICIENCY N=1. TREATMENT: NOT REPORTED. CASE 4: N=1 TWIN A1. DELAYED HEALING OF EPIGASTRIUM COMPLICATED BY A CANDIDA INFECTION. TREATMENT: NOT REPORTED. N=1 TWIN A2. PERIUMBILICAL HERNIA. TREATMENT: SURGICAL CORRECTION WITH AUTOLOGOUS ABDOMINAL TISSUE AND PRE-EXISTING BIOLOGIC MESH. IN CONCLUSION, IN OUR CASE SERIES, WE SHOW THE OPERATIVE TECHNIQUE AND SURGICAL MANAGEMENT FOR THE SEPARATION OF 4 CASES OF THORACO OMPHALOPAGUS TWINS. OUR PREFERRED SURGICAL METHOD OF SEPARATION SURROUNDS THE USE OF TISSUE EXPANDERS WITH MESH FASCIAL BOLSTERING FOR DEVELOPING ROBUST SOFT TISSUE FOR CLOSURE. WE OBSERVED FEW COMPLICATIONS AND PROPER WOUND CLOSURE IN ALL THE EXAMINED CASES SHOWED FURTHER PROOF OF TISSUE EXPANDER AND MESH VALIDITY IN THESE COMPLEX CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1634058 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other