BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 19766565 · Received July 17, 2024

    Report

    Report Number
    2210968-2024-07326
    Event Type
    Injury
    Date Received
    July 17, 2024
    Date of Event
    January 1, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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. AN ATTEMPT HAS BEEN 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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: EUROPEAN REVIEW FOR MEDICAL AND PHARMACOLOGICAL SCIENCES. VOL. 27: PAGES 8234-8244. PLEASE SEE ARTICLE ATTACHED.

    Description of Event or Problem · 0

    TITLE : THE ROLE OF COMPONENT SEPARATION IN THE TREATMENT OF SEVERE DIASTASIS RECTI ABDOMINIS: A NEW INDICATION FOR A KNOWN TECHNIQUE THE AIM OF THIS STUDY WAS TO REPORT OUR EXPERIENCE GAINED BY APPLYING THE COMPONENT SEPARATION TECHNIQUE IN CASES OF SEVERE DRAM (> 10 CM). AS FAR AS WE KNOW, THIS IS THE FIRST STUDY THAT DESCRIBES THE USE OF THIS TECHNIQUE TO REPAIR DRAM, ASSOCIATED TO ABDOMINOPLASTY SURGERY. FROM JANUARY 2015 TO DECEMBER 2018, 43 PATIENTS WERE TREATED IN THE UNIT OF PLASTIC AND RECONSTRUCTIVE SURGERY, DEPARTMENT OF SURGERY, UNIVERSITY OF PERUGIA AND IN PLASTIC SURGERY DEPARTMENT ¿P. VALDONI¿ OF SAPIENZA UNIVERSITY ROME, FOR DRA REPAIR AND WERE THEN FOLLOWED UP. ALL PATIENTS WERE FEMALE, AGE RANGED BETWEEN 32 AND 62 YEARS (MEAN: 49 YEARS OLD, MEDIAN: 38 YEARS 3 MONTHS). THIS MOBILIZATION ALLOWED PRIMARY CLOSURE OF THE DEFECT WITH MINIMAL TENSION USING AN INTERRUPTED FIGURE-OF-EIGHT 0 POLYPROPYLENE SUTURE ( PROLENE; ETHICON, INC, SOMERVILLE, NJ, USA). THEREBY APPROXIMATING ADJACENT FASCIA WAS REPAIRED BY DIRECT APPROXIMATION, REINFORCING THE REPAIR, AND IMPROVING THE CONTOUR AND TONE OF THE LAX ABDOMINAL WALL USING AN UNINTERRUPTED 2/0 POLYDIOXANONE SUTURE ( PROLENE; ETHICON, INC, SOMERVILLE, NJ, USA). SKIN CLOSURE WAS CARRIED OUT WITH INTERRUPTED DEEP 2/0 POLYDIOXANONE SUTURES ( VICRYL, ETHICON, INC, SOMERVILLE, NJ, USA), DERMAL 3/0 POLIGLECAPRONE 25 (MONOCRYL, ETHICON, INC.) AND UNINTERRUPTED CUTANEOUS 3/0 NYLON ( ETHILON, ETHICON, SOMERVILLE, NJ, USA). THIRTEEN DEVICES WERE PARTIALLY ABSORBABLE POLYPROPYLENEPOLIGLECAPRONE MONOFILAMENT LIGHTWEIGHT MESHES (ULTRAPRO® PARTIALLY ABSORBABLE LIGHTWEIGHT MESH, ETHICON, JOHNSON & JOHNSON COMPANY, AMERSFOORT, THE NETHERLANDS) AND FIVE WERE NON-ABSORBABLE POLYPROPYLENE MONOFILAMENT HEAVYWEIGHT MESHES (PROLENE® POLYPROPYLENE HERNIA SYSTEM, ETHICON, JOHNSON & JOHNSON COMPANY, AMERSFOORT, THE NETHERLANDS). THE REPORTED COMPLICATIONS INCLUDED SEROMA (N=5), DEHISCENCE (N=4), UMBILICUS SUPERFICIAL SKIN NECROSIS (N=2) AND PARTIAL SKIN FLAP NECROSIS (N=1). IN CONCLUSION, THIS IS THE FIRST STUDY DESCRIBING THE COMPONENT SEPARATION TECHNIQUE USE IN CASES OF DRA WITHOUT HERNIA, ASSOCIATED TO ABDOMINOPLASTY SURGERY. PRELIMINARY RESULTS WERE ENCOURAGING, BUT LARGER SERIES ARE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352265 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention