BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7635983 · Received June 25, 2018

    Report

    Report Number
    2210968-2018-73773
    Event Type
    Injury
    Date Received
    June 25, 2018
    Report Date
    June 5, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    TITLE: 2-0 PROLENE BROW SUSPENSION FOR PAEDIATRIC PTOSIS: A RETROSPECTIVE CASE SERIES OF 37 EYESTHE AIM OF THIS RETROSPECTIVE CASE REVIEW WAS TO ASSESS THE EFFICACY OF 2-0 PROLENE BROW SUSPENSION SURGERY IN PAEDIATRIC PTOSIS WITH POOR LEVATOR FUNCTION. BETWEEN 1997 AND 2007, 27 (37 EYES) PATIENTS (11 FEMALES AND 16 MALES) UNDER THE AGE OF 10 YEARS WHO UNDERWENT 2-0 PROLENE BROW SUSPENSIONS FOR CONGENITAL PTOSIS WERE INCLUDED IN THE STUDY. DURING THE PROCEDURE, A LID GUARD WAS PLACED ON THE PATIENT. WRIGHT¿S NEEDLE WAS USED TO THREAD THE 2-0 PROLENE SUTURE (WITH THE NEEDLE REMOVED) BELOW THE SUBCUTANEOUS TISSUE IN THE LID, IN A PLANE JUST SUPERFICIAL TO THE TARSAL PLATE AND IN THE BROW SUPERFICIAL TO THE FASCIAL PLANE. IN VERY SMALL CHILDREN THE SUTURE WAS THREADED ONTO A SURGICAL NEEDLE. PTOSIS RECURRED IN 10 EYELIDS OF WHICH 6 WENT ON TO HAVE FURTHER SURGERY IN THE FORM OF FASCIA LATA BROW SUSPENSION AND 4 HAD REPEAT 2-0 PROLENE BROW SUSPENSION. IN ONE EYELID THE PTOSIS RECURRED FOLLOWING LID TRAUMA (HITTING HEAD DURING A SEIZURE) AND NEEDED TO BE RE-ADJUSTED USING THE EXISTING PROLENE SUTURE. OF THE 4 CASES THAT HAD A SECOND 2-0 PROLENE PROCEDURE ALL CASES ACHIEVED FUNCTIONAL SUCCESS WITH A MEAN FOLLOW-UP OF 36.75 MONTHS. IN CONCLUSION, THE RESULTS FROM THIS SERIES INDICATE THAT IN MOST CASES A PROLENE BROW SUSPENSION PROVIDES A LONG TERM RESULT AND A SECOND PROCEDURE CAN BE COMPLETELY AVOIDED OR AT LEAST DELAYED UNTIL THE CHILD IS MUCH OLDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475715 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention