BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 19127578 · Received April 17, 2024

    Report

    Report Number
    2210968-2024-04459
    Event Type
    Injury
    Date Received
    April 17, 2024
    Date of Event
    January 29, 2023
    Report Date
    April 17, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    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. RELATED EVENTS CAPTURED VIA 2210968-2024-04460. CITATION: JOURNAL OF PLASTIC, RECONSTRUCTIVE & AESTHETIC SURGERY 80 (2023). HTTPS://DOI.ORG/10.1016/J.BJPS.2023.01.047 1748-6815.

    Description of Event or Problem · 0

    TITLE: A SINGLE SURGEON'S EXPERIENCE WITH MOTIVA ERGONOMIX ROUND SILKSURFACE SILICONE IMPLANTS IN BREAST RECONSTRUCTION OVER A 5-YEAR PERIOD.THE AIM OF THIS STUDY IS TO DESCRIBE A SINGLE SURGEON'S EXPERIENCE WITH MOTIVA ERGONOMIX, SILK-TEXTURED, ROUND IMPLANT FOR BREAST RECONSTRUCTION. A RETROSPECTIVE CHART REVIEW OF ALL PATIENTS UNDERGOING PRIMARY OR REVISIONARY BREAST RECONSTRUCTION PROCEDURES, USING MOTIVA ERGONOMIX, FROM JANUARY 2017 TO JANUARY 2022. DURING THE PROCEDURE, IF A PRE-PECTORAL APPROACH IS SELECTED, THE IMPLANT IS WRAPPED WITH TWO SHEETS OF THE MASHED ACELLULAR DERMAL MATRIX (ADM) (DERMACELL - COMPETITOR). THE TWO 16 * 8 CM PIECES OF ADM ARE SUTURED TOGETHER, WRAPPED AROUND THE FRONT ASPECT OF THE IMPLANT, AND CONNECTED WITH A FOUR-CORNER SUTURE ON THE BACKSIDE USING VYCRIL 0 (ETHICON). THE WRAPPED IMPLANT IS THEN STABILIZED IN THE BREAST POCKET'S PRE-MARKED LOCATION WITH A SERIES OF VYCRIL 0 SUTURES (ETHICON). THE INCISIONS ARE SUTURED WITH VYCRIL 3/0, MONOCRYL 3/0 (ETHICON). REPORTED COMPLICATION:HEMATOMA (N-4).SEROMA (N-6).CONCLUSION: THIS COHORT DESCRIBES THE CURRENT MOST EXTENSIVE EXPERIENCE WITH MOTIVA ERGONOMIX IMPLANT USED FOR RECONSTRUCTIVE SURGERIES. OUR STUDY COHORT CONSISTED OF 156 PATIENTS (269 BREASTS) OVER A 5-YEAR PERIOD. THIS ARTICLE DELINEATES MOTIVA ERGONOMIX ROUND SILKSURFACE SILICONE BREAST IMPLANTS. MOTIVA'S IMPLANTS PRESENT A UNIQUE SET OF TECHNOLOGIES THAT LOWER COMPLICATION RATES, ESPECIALLY CAPSULAR CONTRACTURE. OUR SERIES SHOWS THAT MOTIVA¿S NEW IMPLANT PROVIDES A SAFE AND RELIABLE ALTERNATIVE TO BREAST RECONSTRUCTIVE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1339480 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention