BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 16908453 · Received May 10, 2023

    Report

    Report Number
    2210968-2023-03522
    Event Type
    Injury
    Date Received
    May 10, 2023
    Date of Event
    December 22, 2021
    Report Date
    May 10, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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 2210968-2023-03522, 2210968-2023-03523. CITATION: PLAST. RECONSTR. SURG. 150: 1248, 2022; HTTPS://DOI.ORG/10.1097/PRS.0000000000009740.

    Description of Event or Problem · 0

    TITLE: DECISION-MAKING ALGORITHM FOR ADVANCED EXCISIONAL BODY CONTOURING: DYNAMIC DEFINITION SOLUTIONS FOR SKIN LAXITY THE AUTHORS DESCRIBE THEIR EXPERIENCE USING A DECISION-MAKING ALGORITHM AS A TOOL TO EASE SURGICAL PLANNING FOR ADVANCED EXCISIONAL BODY CONTOURING. FROM (B)(6) 2020, 563 WOMEN WHO WERE CLASSIFIED ACCORDING TO SKIN LAXITY AND NAVEL LOCATION TO UNDERGO ONE OF THE FOLLOWING PROCEDURES: MIXED TECHNOLOGIES PLUS UMBILICAL MOBILIZATION, MIXED TECHNOLOGIES PLUS SLIDING MINI-ABDOMINOPLASTY, MINI-TUMMY TUCK WITH MUSCULAR PLICATION, FULL ABDOMINOPLASTY, REVERSE BRIDGE ABDOMINOPLASTY, OR REVERSE FULL ABDOMINOPLASTY WERE INCLUDED IN THE STUDY. MEAN BODY MASS INDEX WAS 25.7 KG/M2 AND THE AVERAGE PATIENT AGE WAS 34 YEARS (RANGE, 22 TO 66 YEARS). PATIENTS WHO DESIRED CORRECTION OF DIASTASIS RECTI UNDERWENT MINI-ABDOMINOPLASTY WITH MUSCULAR PLICATION (139 PATIENTS), FULL ABDOMINOPLASTY (327 PATIENTS) OR REVERSE FULL ABDOMINOPLASTY (27 PATIENTS) WERE PERFORMED. FOR THE MUSCULAR PLICATION PROCEDURES, VICRYL SUTURE (ETHICON) WAS USED FOR PATIENTS WHO DESIRE A FUTURE PREGANCY AND NUROLON (ETHICON) WAS USED FOR THOSE WHO DO NOT. THE REPORTED COMPLICATIONS INCLUDED SEROMA (N=10), PROLONGED BRUISING (N=16), PROLONGED SWELLING (N=23), AND LOCAL INFECTION (N=3). IN CONCLUSION, THIS ALGORITHM HELPED THE AUTHORS CHOOSE THE BEST EXCISIONAL TECHNIQUE BASED ON PATIENTS¿ ANATOMICAL FEATURES BY FOLLOWING SKIN GEOMETRY TO ENHANCE AESTHETIC OUTCOMES. FURTHER STUDIES ARE NEEDED TO SUPPORT THE ALGORITHM VALIDATION AND AESTHETIC OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881996 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention