BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7371548 · Received March 26, 2018

    Report

    Report Number
    2210968-2018-71660
    Event Type
    Injury
    Date Received
    March 26, 2018
    Report Date
    March 2, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 VICRYL SUTURE CAUSED AND/OR CONTRIBUTED TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE? CITATION: PEDIATR SURG INT (2010) 26:967¿970; DOI 10.1007/S00383-010-2648-8. (B)(4).

    Description of Event or Problem · 1

    TITLE: WHAT IS THE MOST COMMON COMPLICATION AFTER ONE-STAGE TRANSANAL PULL-THROUGH IN INFANTS WITH HIRSCHSPRUNG¿S DISEASE? THIS PROSPECTIVE STUDY AIMED TO EVALUATE INFANTS WITH HIRSCHSPRUNG¿S DISEASE (HD) WHO UNDERWENT ONE-STAGE TRANSANAL PULL-THROUGH (TAPT) IN TERMS OF FUNCTIONAL AND CLINICAL OUTCOME AND ANALYZED POSTOPERATIVE COMPLICATIONS. DURING A 4-YEAR REVIEW, FROM FEB2006 TO DEC2009, 86 NEONATES (N=57 BOYS, N=28 GIRLS; MEAN AGE OF 8 DAYS) WERE INCLUDED. IN THE PROCEDURE, THE ANASTOMOSIS WAS DONE BETWEEN THE WELL BLOOD SUPPLY AND GANGLIONIC COLON PULLED DOWN AND THE RECTAL WALL LAYER ABOVE DENTATE LINE AT STARTING POINT OF DISSECTION BY USING INTERRUPTED 5-0 VICRYL SUTURE. POSTOPERATIVE COMPLICATIONS INCLUDED RETROCOLIC ABSCESS (N=2) AND ANASTOMOTIC STRICTURE (N=12). RETROCOLIC ABSCESS WERE TREATED WITH SPONTANEOUS DRAINAGE VIA TUBE DRAIN. FOR ANASTOMOTIC STRICTURE, 10 PATIENTS WERE TREATED WITH SERIAL DILATATION REQUIRED WITH HEGAR DILATORS, AND 2 PATIENTS REQUIRED A RECTAL DILATORS UNDER ANESTHESIA. STRICTURE FORMATION HAS BEEN PROPOSED TO BE CAUSED FROM DIFFERENT FACTORS SUCH AS LACK OF BLOOD SUPPLY, TENSION ON THE ANASTOMOSIS, SURGICAL TECHNIQUE, AND POSTOPERATIVE MANAGEMENT. IN THE AUTHORS EXPERIENCE, STRICTURE FORMATION CAN BE PREVENTED BY THE PROPHYLACTIC BOUGINAGE WITH HEGAR PROBE TWO WEEKS AFTER SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215163 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention