BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 12309987 · Received August 11, 2021

    Report

    Report Number
    2210968-2021-07245
    Event Type
    Injury
    Date Received
    August 11, 2021
    Date of Event
    October 19, 2020
    Report Date
    July 29, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS ARE BEING MADE TO CLARIFY 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? 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. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2021-07246. CITATION: ANN SURG ONCOL (2021) 28:2599¿2608 HTTPS://DOI.ORG/10.1245/S10434-020-09225-8.

    Description of Event or Problem · 1

    TITLE: REDUCING SEROMA FORMATION AND ITS SEQUELAE AFTER MASTECTOMY BY CLOSURE OF THE DEAD SPACE: A MULTI-CENTER, DOUBLE-BLIND RANDOMIZED CONTROLLED TRIAL (SAM-TRIAL). THIS STUDY AIMED TO ASSESS THE EFFECT OF FLAP FIXATION USING SUTURES OR TISSUE GLUE IN PREVENTING SEROMA FORMATION AND ITS SEQUELAE. BETWEEN JUNE 2014 AND JULY 2018, A TOTAL OF 339 PATIENTS UNDERWENT ONE OF THREE STUDY ARMS: CONVENTIONAL CLOSURE (CON; N = 115, 33.9%), FLAP FIXATION WITH SUTURES (FFS; N = 111, 32.7%), OR FLAP FIXATION WITH TISSUE GLUE (FFG; N = 113, 33.3%). FOR SKIN CLOSURE, THE EDGES WERE SUTURED USING ABSORBABLE MONOFILAMENT SUTURES (MONOCRYL 3.0). VICRYL 3.0 WAS USED FOR FLAP FIXATION USING SUTURES. (N=40) SEROMA THUS HAD SEROMA ASPIRATIONS. (N=56) SURGICAL SITE INFECTION. THEY WERE TREATED WITH ANTIBIOTICS. (N=30) REOPERATION. (N=?) SLIGHT DETERIORATION OF SHOULDER FUNCTION. FLAP FIXATION USING SUTURES LEADS TO A SIGNIFICANT REDUCTION IN ASPIRATIONS OF POST-MASTECTOMY SEROMAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203936 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention