BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7569772 · Received June 5, 2018

    Report

    Report Number
    2210968-2018-73298
    Event Type
    Injury
    Date Received
    June 5, 2018
    Report Date
    May 28, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. CITATION: EYE (2011) 25, 735¿739; DOI:10.1038/EYE.2011.32 - [(B)(4) - CHOW 2011.PDF].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: ¿TITLE: PROLENE FRONTALIS SUSPENSION IN PAEDIATRIC PTOSIS¿ AUTHOR(S): K CHOW, N DEVA AND SGJ NG CITATION: EYE (2011) 25, 735¿739; DOI:10.1038/EYE.2011.32. THE AIM OF THIS RETROSPECTIVE CHART STUDY WAS TO ASSESS THE EFFICACY OF FRONTALIS SUSPENSION USING 4¿0 PROLENE SUTURES FOR PAEDIATRIC PTOSIS WITH POOR LEVATOR FUNCTION. FROM 2000 TO 2008, 23 PATIENTS (N=30 EYELIDS; N=13 MALE AND N=10 FEMALE; MEAN AGE ± SD OF 22.0±22.7 YEARS) WITH CONGENITAL MYOGENIC PTOSIS (N=17), BLEPHAROPHIMOSIS SYNDROME (N=5) AND MARCUS GUNN JAW-WINKING PTOSIS (N=1) UNDERWENT UNILATERAL OR BILATERAL FRONTALIS SUSPENSION SURGERY FOR PAEDIATRIC PTOSIS WITH POOR LEVATOR FUNCTION. IN THE PROCEDURE, A 4¿0 PROLENE SUTURE WAS PASSED TRANSVERSELY, PARTIAL THICKNESS, THROUGH THE UPPER LID TARSAL PLATE. THE NEEDLE OF THE PROLENE SUTURE WAS THEN REMOVED. POSTOPERATIVELY, PATIENTS HAD PTOSIS RECURRENCE WHICH INCLUDED A (B)(6) YEARS AND (B)(6) MONTH OLD PATIENT WHO UNDERWENT BILATERAL SURGERY DEVELOPED LEFT PTOSIS RECURRENCE 1 MONTH POST-SURGERY. ALL PATIENTS UNDERWENT REVISION. ONE PATIENT DEVELOPED REDNESS ON ONE LID AFTER SURGERY AND WAS REGARDED AS A WOUND INFECTION WHICH WAS TREATED WITH ORAL ANTIBIOTICS, AND RESOLVED WITHIN A FEW DAYS WITHOUT LONG-TERM SEQUELAE. THE CAUSES OF THESE EARLY RECURRENCES WERE INDETERMINATE IN ONE CHILD, KNOT FAILURE (N=1), SUTURE BREAKAGE FROM DIRECT TRAUMA (N=2; CHILDREN HITTING THEIR HEADS WHEN PLAYING) AND ONE RECURRENCE OCCURRED 19 MONTHS POSTOPERATIVELY WITHOUT AN IDENTIFIED CAUSE. SUTURE EXTRUSION WAS NOT SEEN IN THE STUDY DUE TO BURYING PROLENE SUTURES WITHIN THE SUBCUTANEOUS TISSUES AND ITS LOW TISSUE REACTIVITY. PROLENE FRONTALIS SUSPENSION IS AN EFFECTIVE TECHNIQUE FOR THE TREATMENT OF PAEDIATRIC PTOSIS WITH POOR LEVATOR FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411670 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention