BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 7759980 · Received August 7, 2018

    Report

    Report Number
    2210968-2018-74990
    Event Type
    Injury
    Date Received
    August 7, 2018
    Report Date
    July 30, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CITATION: 2009 BJU INTERNATIONAL 105, 1440 ¿ 1444 / DOI:10.1111/J.1464-410X.2009.08991.X. [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: PENOSCROTAL PLICATION AS A UNIFORM APPROACH TO RECONSTRUCTION OF PENILE CURVATURE". AUTHORS: DANIEL D. DUGI III AND ALLEN F. MOREY. CITATION: 2009 BJU INTERNATIONAL 105, 1440 ¿ 1444 / DOI:10.1111/J.1464-410X.2009.08991.X. THIS STUDY AIMED TO PRESENT THE AUTHORS EXPERIENCE WITH PENOSCROTAL PLICATION (PSP) AS A UNIFORM SURGICAL APPROACH FOR MEN WITH SIGNIFICANT PENILE CURVATURE AND INTACT ERECTILE FUNCTION. DURING A 4-YEAR PERIOD FROM 2005 TO 2009, 48 MALE PATIENTS (MEDIAN AGE OF 58.7 YEARS [24-71 YEARS]) WITH SIGNIFICANT PENILE CURVATURE UNDERWENT TUNICA ALBUGINEA PSP. IN THE PROCEDURE, ETHIBOND SUTURES WERE PLACED OPPOSITE THE AREA OF MAXIMUM CURVATURE FOR WHICH EACH SUTURE SPANS A TOTAL OF ¿15 MM. THE PROCEDURE WAS CONSIDERED COMPLETE WHEN ALL MEMBERS OF THE SURGICAL TEAM AGREED THAT THE CURVATURE HAD BEEN COMPLETELY CORRECTED. IMMEDIATELY POSTOPERATIVE, MILD PAIN WITH ERECTION WAS COMMON IN THE PATIENTS, BUT WAS GENERALLY SELF-LIMITED. AT 6 WEEKS AFTER SURGERY, 3 PATIENTS HAD ERECTILE PAIN FOR WHICH TWO HAD A SUTURE RELEASED PROCEDURE. TWO PATIENTS WERE DISSATISFIED WITH THE STRAIGHTENING/RECURRENT OF CURVATURE; A YOUNG MAN WITH CONGENITAL PENILE CURVATURE WHO HAD REPEAT PLICATION, AND A PATIENT WITH PEYRONIE¿S DISEASE HAD CONTINUED CURVATURE AND WORSENED ERECTILE DYSFUNCTION TREATED WITH INSERTION OF A PENILE PROSTHESIS. THE AUTHORS CAUTIONED THAT MANY SUTURES (UP TO 17) MIGHT BE REQUIRED TO EFFECTIVELY STRAIGHTEN COMPLEX DEFORMITIES AND THAT TRANSIENTLY PAINFUL ERECTIONS MIGHT BE MORE LIKELY AFTER SURGERY. THE FINDINGS ADD TO AN EMERGING BODY OF EVIDENCE THAT SHORTENING OF THE PENIS OCCURS PRIMARILY DUE TO THE PEYRONIE¿S PLAQUE FORMATION AND NOT DUE TO PLICATION SURGERY. PSP IS A SAFE AND EFFECTIVE TECHNIQUE WHICH IS WIDELY APPLICABLE FOR RECONSTRUCTING PENILE SHAFT CURVATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601425 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention