BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7410708 · Received April 10, 2018

    Report

    Report Number
    2210968-2018-72028
    Event Type
    Injury
    Date Received
    April 10, 2018
    Report Date
    March 21, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. CITATION: EUR J SURG. 1995; 161: 655 661. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED IN JOURNAL ARTICLE TITLE: MECHANICAL FACTORS INFLUENCING THE INCIDENCE OF BURST ABDOMEN AUTHORS: ARTHUR H. P. NIGGEBRUGGE, BETTINA E. HANSEN, J. BAPTIST TRIMBOS, CORNELIS J.H. VAN DE VELDE, ALBERT ZWAVELING CITATION: EUR J SURG. 1995; 161: 655 661. THE OBJECTIVES OF THIS RETROSPECTIVE STUDY WAS TO COMPARE LAPAROTOMY CLOSURE WITH INTERRUPTED VICRYL SUTURES AND CONTINUOUS PDS II AND ASSESS THE MECHANICAL AND OTHER FACTORS THAT INFLUENCED THE INCIDENCE OF BURST ABDOMEN. A TOTAL OF 391 PATIENTS UNDERWENT MIDLINE LAPAROTOMY AND WERE INCLUDED IN THE STUDY. OF WHICH, 45 PATIENTS HAD A BURST ABDOMEN (VICRYL SUTURES [N-32] AND PDS II SUTURES [N-13]) WHICH NECESSITATES A SECOND OPERATION AND 346 PATIENTS HAD NO BURST ABDOMEN (VICRYL SUTURES [N-204] AND PDS II SUTURES [N-142]). IN THE BURST ABDOMEN GROUP, OTHER REPORTED COMPLICATIONS INCLUDED WOUND HEMATOMA (N-7), ILEUS (N-7), AND WOUND INFECTION (N-14). IN THE NO BURST GROUP, REPORTED COMPLICATIONS INCLUDED WOUND HEMATOMA (N-7), ILEUS (N-13), AND WOUND INFECTION (N-33). IT WAS REPORTED THAT THE CAUSE OF BURST ABDOMEN WERE DUE TO TORN TISSUE DISRUPTIONS (VICRYL SUTURE 63% AND PDS II 69%), BROKEN SUTURE (VICRYL 37% AND PDS II 15%), AND SLIPPED KNOT (PDS II 15 %). IT WAS CONCLUDED THAT CONTINUOUS, MONOFILAMENT, ABSORBABLE SUTURE SHOULD BE USED TO CLOSE A LAPAROTOMY INCISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258530 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention