BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VICRYL RAPIDE SUTURE

    MDR report key: 20833439 · Received December 3, 2024

    Report

    Report Number
    2210968-2024-12758
    Event Type
    Injury
    Date Received
    December 3, 2024
    Date of Event
    January 19, 2024
    Report Date
    December 3, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K033746
    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. 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. CITATIONS : AESTHETIC SURGERY JOURNAL. VOL 44(6) 633¿640. HTTPS://DOI.ORG/10.1093/ASJ/SJAE006.

    Description of Event or Problem · 0

    TITLE : CORRECTION OF RECTUS ABDOMINIS DIASTASIS: A PROSPECTIVE COMPARATIVE STUDY BETWEEN A NEW SUTURABLE POLYPROPYLENE MESH VS POLYPROPYLENE STANDARD SUTURE PLICATION. THE AIM OF THIS STUDY WAS TO COMPARE MESH WITH THE STANDARD POLYPROPYLENE SUTURE PLICATION FOR RECTUS DIASTASIS REPAIR WITH REGARD TO SAFETY (INFECTION, SEROMA, HEMATOMA, SURGICAL WOUND DEHISCENCE, AND FISTULA RATES AND HOSPITAL STAY); EFFECTIVENESS (ARD RECURRENCE BY ULTRASOUND SONOGRAPHY, PALPABILITY OF THE MUSCULAR SUTURE, SURGICAL TIME, AND POSTOPERATIVE PAIN EVALUATION); AND SATISFACTION OF THE PATIENTS BASED ON THE BODY-Q, A PATIENT-REPORTED OUTCOME MEASURE. SIXTY-FIVE OF THE INITIAL 70 PATIENTS WHO UNDERWENT RECTUS DIASTASIS REPAIR WITH A 6-MONTH FOLLOW-UP WERE RANDOMLY DIVIDED INTO 2 GROUPS, COMPRISING 33 PATIENTS TREATED WITH DURAMESH AND 32 PATIENTS TREATED WITH STANDARD 0 POLYPROPYLENE SUTURE PLICATION. ANY HERNIA LOCATED WAS REDUCED, AND ITS BREACH WAS SUTURED WITH 2-0 VICRYL (ETHICON, RARITAN, NJ). A LAYERED SUTURE WAS PERFORMED WITH 2-0 VICRYL, 3-0 VICRYL, AND 4-0 VICRYL RAPIDE. THE REPORTED COMPLICATIONS INCLUDED INFECTION (N=1) , SEROMA (N=4), HEMATOMA (N=3) AND SURGICAL WOUND DEHISCENCE (N=7). IN CONCLUSION, DURAMESH 0 APPLICATION FOR RECTUS DIASTASIS REPAIR IS SAFE AND EFFECTIVE WITHOUT COMPROMISING AESTHETIC IMPROVEMENT WHEN COMPARED WITH STANDARD 0 POLYPROPYLENE PLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2245839 UNKNOWN VICRYL RAPIDE SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other