BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 11458026 · Received March 10, 2021

    Report

    Report Number
    2210968-2021-02228
    Event Type
    Injury
    Date Received
    March 10, 2021
    Date of Event
    May 20, 2018
    Report Date
    March 1, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: 03/10/2021. ADDITIONAL INFORMATION: ARTICLE ATTACHED. 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.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). (B)(4). 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: THE JOURNAL OF UROLOGY E903: PEDIATRIC UROLOGY V09-02 / VOL. 199, NO. 4S, SUPPLEMENT, SUNDAY, MAY 20, 2018. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    TITLE: ABDOMINOPLASTY WITHOUT OSTEOTOMIES USING GROIN FLAPS TO CLOSE THE ABDOMINAL WALL DEFECT IN THE MANAGEMENT OF EXSTROPHY-EPISPADIAS COMPLEX. THE AIM OF THIS STUDY IS TO DESCRIBE THE GROIN FLAP TECHNIQUE TO CLOSE THE ABDOMINAL WALL OF CHILDREN WITH EXSTROPHY-EPISPADIA COMPLEX WITHOUT OSTEOTOMY AND WITHOUT RADICAL SOFT TISSUE MOBILIZATION. DURING THE LAST 30 YEARS, GROIN FLAP WAS APPLIED TO 128 PATIENTS WITH BLADDER EXSTROPHY BUT ONLY 44 HAD REGULAR FOLLOW UPS. GROIN FLAPS WERE MADE OF THE RECTUS ANTERIOR APONEUROSES ROTATED MEDIALLY, FLIPPED OVER, AND SUTURED WITH PROLENE (ETHICON) SUTURES TO CLOSE THE DEFECT. ONE PATIENT HAD COMPLETE WOUND DEHISCENCE (N=1) THAT NEEDED ANOTHER RECONSTRUCTION AND FOUR PATIENTS PRESENTED ABDOMINAL HERNIAS (N=4) THAT NEEDED SURGICAL MANAGEMENT. ONE-STAGED RECONSTRUCTION USING GROIN FLAPS HAS ADVANTAGES OVER THE TRADITIONAL APPROACHES TO BLADDER EXSTROPHY. IT REDUCES THE SURGICAL STEPS AND FACILITATES THE CLOSURE OF THE ABDOMINAL WALL WITHOUT THE NEED OF OSTEOTOMIES AND CONSEQUENT IMMOBILIZATION DURING THE POSTOPERATIVE PERIOD. IT IS FEASIBLE AT ANY AGE AND CAN BE ALSO VERY USEFUL AS A RESCUE TECHNIQUE EVEN AFTER PREVIOUS FAILED PROCEDURES. FINALLY, IT MINIMIZES THE NUMBER OF SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348480 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention