BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT

    MDR report key: 8412459 · Received March 12, 2019

    Report

    Report Number
    2210968-2019-79391
    Event Type
    Injury
    Date Received
    March 12, 2019
    Report Date
    February 15, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. CITATION: PLOS ONE 13(10): E0203993. DOI: HTTPS://DOI.ORG/10.1371/JOURNAL.PONE.0203993. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE: CORNEAL TRANSPLANTATION FOR FUCHSÂ ENDOTHELIAL DYSTROPHY: A COMPARISON OF THREE SURGICAL TECHNIQUES CONCERNING 10 YEAR GRAFT SURVIVAL AND VISUAL FUNCTION". AUTHOR(S): JEROEN VAN ROOIJID, ELSINA H. LUCAS, ANNETTE J. GEERARDS, LIES REMEIJER, RENE WUBBELS. CITATION: PLOS ONE 13(10): E0203993. DOI: HTTPS://DOI.ORG/10.1371/JOURNAL.PONE.0203993. THE PURPOSE OF THIS RETROSPECTIVE STUDY WITH A STRUCTURED PROSPECTIVE FOLLOW-UP WAS TO REPORT GRAFT SURVIVAL, THE DIFFERENCES IN POSTOPERATIVE VISUAL ACUITY AND REFRACTIVE CHANGES FOR THREE TRANSPLANTATION TECHNIQUES (PENETRATING KERATOPLASTY [PKP], POSTERIOR MUSHROOM PKP AND DESCEMET'S STRIPPING AUTOMATED ENDOTHELIAL KERATOPLASTY [DSAEK]) APPLIED TOFUCHS' ENDOTHELIAL DYSTROPHY (FED) EYES OPERATED IN THE ROTTERDAM EYE HOSPITAL (REH). BETWEEN 2001 AND 2013, 721 PATIENTS UNDERWENT PRIMARY CORNEAL TRANSPLANTS USING THREE TECHNIQUES: PKP (171; N=70 MALE AND N=101 FEMALE; MEAN AGE OF 72.3±9.4 YEARS); POSTERIOR MUSHROOM PKP (91; N=42 MALE AND N=49 FEMALE; MEAN AGE OF 73.6±8.0 YEARS); AND DSAEK (N=459; N=208 MALE AND N=251 FEMALE; MEAN AGE OF 71.0±9.2 YEARS). IN ALL PROCEDURES, MERSILENE SUTURES WERE REMOVED SELECTIVELY WITHIN TWO YEARS. POTENTIALLY SURGERY-RELATED ADVERSE EVENTS INCLUDED BACTERIAL OR VIRAL INFECTION (N=7 PKP GROUP, N=1 MUSHROOM PKP GROUP, N=1 DSAEK GROUP); AND ONE POSTERIOR MUSHROOM PKP EYE HAD TO BE EVISCERATED. THERE WAS NO DIFFERENCE IN GRAFT SURVIVAL AND BSCVA IMPROVEMENT BETWEEN CONVENTIONAL PKP, INVERTED MUSHROOM PKP AND DSAEK IN THIS STUDY. THE SIGNIFICANTLY LOWER CHANGES IN ASTIGMATISM, WOUND STABILITY AND FASTER VISUAL REHABILITATION WITH DSAEK SURGERY ARE FAVOURABLE ASPECTS OF THIS TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205655 MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention