BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 22136398 · Received June 3, 2025

    Report

    Report Number
    2210968-2025-06187
    Event Type
    Injury
    Date Received
    June 3, 2025
    Date of Event
    August 25, 2021
    Report Date
    June 3, 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
    PL
    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: ARCH MED SCI. 2021 AUG 25;21(1):153-159. HTTPS://DOI.ORG/10.5114/AOMS/141229. PMID: 40190323; PMCID: PMC11969540.

    Description of Event or Problem · 0

    TITLE: A NOVEL TECHNIQUE FOR IMMEDIATE NIPPLE RECONSTRUCTION WITH A RECTANGULAR FLAP IN IMPLANT-BASED BREAST RECONSTRUCTION. THE AIM OF THIS STUDY IS TO DESCRIBE THE EXPERIENCES WITH IMMEDIATE IMPLANT-BASED BREAST RECONSTRUCTION MODIFIED BY RESTORING THE NIPPLE WITH A RECTANGULAR SKIN FLAP. IN CONTRAST TO THE FORMER TECHNIQUES, OUR METHOD IS SIMPLE AS IT DIRECTLY ADAPTS THE CONVENTIONAL ELLIPTICAL BREAST INCISION. IN ADDITION, THE STUDY WAS CONDUCTED BETWEEN JUNE 2015 AND DECEMBER 2020 AT THE 1ST AND 2ND DEPARTMENT OF SURGICAL ONCOLOGY, COPERNICUS MEMORIAL HOSPITAL IN LODZ AND THE DEPARTMENT OF SURGICAL ONCOLOGY AND BREAST DISEASES, POLISH MOTHER¿S MEMORIAL HOSPITAL ¿ RESEARCH INSTITUTE, LODZ. A TOTAL OF 117 ONE-STAGE NIPPLE RECONSTRUCTIONS WERE PERFORMED IN 112 BREAST CANCER PATIENTS UNDERGOING SKIN-SPARING MASTECTOMY (SSM). THE MEAN AGE OF THE PATIENTS WAS 57 YEARS (RANGE: 35¿79 YEARS). MONOCRYL 3-0 AND 4-0 (ETH) WERE USED TO CLOSED THE WOUND AND PROLENE 5-0 (ETH) WAS USED TO FOLD THE RECTANGULAR FLAP. REPORTED COMPLICATIONS: MONOCRYL 3-0 AND 4-0 (ETH). PROLENE 5-0 (ETH). PATIENTS (N=112). ISOLATED NIPPLE NECROSIS (N=5). TREATMENT: NOT REPORTED. NIPPLE AND SKIN FLAPS NECROSIS (N=8). TREATMENT: NOT REPORTED. IMPLANT LOSS (N=2). TREATMENT: NOT REPORTED. HEMATOMA (N=4). TREATMENT: SURGICAL REVISION. SURGICAL SITE INFECTION (N=9). TREATMENT: ANTIBIOTIC THERAPY LOSS OF NIPPLE PROJECTION (N=2). TREATMENT: NOT REPORTED. SYMPTOMATIC CAPSULE FIBROSIS (N=5). TREATMENT: NOT REPORTED. IN CONCLUSION, THE APPLIED IMMEDIATE NIPPLE RECONSTRUCTION TECHNIQUE PERFORMED DURING A SKIN-SPARING MASTECTOMY AND IMPLANT/EXPANDER-BASED BREAST RECONSTRUCTION WAS AN EFFECTIVE AND SAFE ADJUNCT CURATIVE BREAST SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358276 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention