BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 7397935 · Received April 4, 2018

    Report

    Report Number
    2210968-2018-71907
    Event Type
    Injury
    Date Received
    April 4, 2018
    Report Date
    March 19, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH 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. ATTEMPTS ARE BEING MADE TO OBTAIN 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ANY DEFICIENCY OF THE ETHICON PRODUCT PDS SUTURE CAUSED AND/OR CONTRIBUTED TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE, SPECIFICALLY THE INFECTION? CITATION: PEDIATR SURG INT. 2015; 31: 809 814. DOI: 10.1007/S00383-015-3749-1. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN JOURNAL ARTICLE TITLE: THE MANAGEMENT OF ANORECTAL MALFORMATION WITH CONGENITAL VESTIBULAR FISTULA: A SINGLE-STAGE MODIFIED ANTERIOR SAGITTAL ANORECTOPLASTY AUTHORS: CHEN WANG, LONG LI, SHULI LIU, ZHENG CHEN, MEI DIAO, XU LI, GUOLIANG QIAO, WEI CHENG CITATION: PEDIATR SURG INT. 2015; 31: 809 814. DOI: 10.1007/S00383-015-3749-1. THE AIM OF THIS STUDY WAS TO EVALUATE THE MID-TERM OUTCOMES OF SINGLE-STAGE MODIFIED ANTERIOR SAGITTAL ANORECTOPLASTY (ASARP) FOR ANORECTAL MALFORMATION WITH VESTIBULAR FISTULA. A TOTAL OF 26 PATIENTS (AGE RANGE: 1 MONTH TO 5.1 YEARS OLD) WITH CONGENITAL IMPERFORATE ANUS AND CONGENITAL VESTIBULAR FISTULA UNDERWENT SINGLE-STAGE MODIFIED SPHINCTER-SAVING ASARP AND WERE INCLUDED IN THE STUDY. DURING THE SURGICAL PROCEDURE, AN ANOPLASTY WAS PERFORMED WITH AN ABSORBABLE PDS II 5-0 SUTURES. THE CLOSURE OF THE SURGICAL WOUND WAS COMPLETED BY CLOSING THE PERINEAL SKIN AND CREATION OF A PERINEAL BODY. REPORTED COMPLICATIONS INCLUDED MINOR WOUND INFECTION (N-3) WHICH REQUIRED ANTIBIOTICS AND MUCOSAL PROLAPSE (N-1) WHO DID NOT REQUIRE SURGICAL INTERVENTION. IT WAS CONCLUDED THAT SINGLE-STAGE MODIFIED ASARP IS AN EFFECTIVE AND SAFE OPTION FOR PATIENTS WITH ANORECTAL MALFORMATION AND CONGENITAL VESTIBULAR FISTULA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238227 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention