BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7328355 · Received March 9, 2018

    Report

    Report Number
    2210968-2018-71384
    Event Type
    Injury
    Date Received
    March 9, 2018
    Report Date
    February 27, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: (B)(4) 2018.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. WAS THE CASE DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT THE CELLULITIS WAS CAUSED BY THE SUTURE? WHAT WAS THE LOCATION AND TISSUE LAYER THAT THE VICRYL SUTURE WAS USED ON? DOES THE SURGEON BELIEVE THERE WAS ANY ALLEGED SUTURE DEFICIENCY THAT LEAD TO THE POST OPERATIVE COMPLICATION IN THIS ARTICLE? IF YES, PROVIDE DETAILS OF EVENT AND SPECIFIC SUTURE PRODUCT CODE AND LOT NUMBER INVOLVED. THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AT THIS TIME AS THE LOT NUMBER HAS NOT BEEN PROVIDED.

    Description of Event or Problem · 1

    ARTICLE TITLE: MODIFICATION OF U-STITCH LAPAROSCOPIC GASTROSTOMY TECHNIQUE TO MINIMIZE SUTURE KNOT ABSCESS FORMATION . AUTHOR(S): JILLIAN MCCAGG SARAH MARKHAM OLAJIRE IDOWU CHRISTOPHER NEWTON BARNARD PALMER SUNGHOON KIM . CITATION: EUR J PEDIATR SURG 2016;26:252¿254. DOI HTTP://DX.DOI.ORG/10.1055/S-0035-1551570. THE RESTROSPECTIVE STUDY AIMED TO PRESENT THE MODIFIED TECHNIQUE OF U-STITCH LAPAROSCOPIC GASTROSTOMY TO DECREASE SUTURE KNOT ABSCESS FORMATION. TWENTY SEVEN PATIENTS (AGES 2 MONTHS TO 12 YEARS), FROM 2013 TO 2014, WHO UNDERWENT LAPAROSCOPIC GASTROSTOMY USING MODIFIED U-STITCH TECHNIQUES WERE INCLUDED. THE TECHNIQUE IS ACHIEVED BY USING TWO U-SUTURES, EITHER 2-0 VICRYL (N=11) OR 2-0 PDS (N=16) SUTURES BEING TUNNELED TOWARD THE GASTROSTOMY TRACT AND TYING THE CONTRALATERAL SUTURES WITHIN THE GASTROSTOMY TRACT. ONE PATIENT WHERE VICRYL SUTURES WAS UTILIZED DEVELOPED CELLULITIS NEAR GASTROSTOMY WHICH CLEARED WITH A COURSE OF ANTIBIOTICS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170585 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention