BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VICRYL RAPIDE SUTURE

    MDR report key: 7456118 · Received April 24, 2018

    Report

    Report Number
    2210968-2018-72326
    Event Type
    Injury
    Date Received
    April 24, 2018
    Report Date
    March 28, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K033746
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE 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 RAPIDE SUTURE CAUSED AND/OR CONTRIBUTED TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE? CITATION: GYNECOL SURG (2012) 9:411¿413; DOI 10.1007/S10397-012-0750-8 - [(B)(4) CROSSLEY 2012.PDF].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: ¿TITLE: PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE THE NEED FOR SKIN SUTURES TO CLOSE LAPAROSCOPIC SKIN INCISIONS¿ AUTHOR(S): S. CROSSLEY & M. HOUDA & M. POWELL CITATION: GYNECOL SURG (2012) 9:411¿413; DOI 10.1007/S10397-012-0750-8. THE AIM OF THIS STUDY WAS TO EVALUATE THE CURRENT PRACTICE OF SUTURING TROCAR INCISION SITES AND THE COSMETIC AND CLINICAL OUTCOMES COMPARED TO A CONTROL GROUP. FIFTY TWO FEMALE PATIENTS, AGED 25 TO 64 YEARS, UNDERWENT LAPAROSCOPY AND WERE ALTERNATELY ALLOCATED INTO SUTURE AND NON-SUTURE GROUP. FIFTY PATIENTS WERE INCLUDED ON THE ANALYSIS. IN THE SUTURE GROUP, 2/0 RAPIDE VICRYL SUTURES WERE USED TO THE INCISION; AND IN NON-SUTURE GROUP, A SIMPLE STERILE DRESSING WAS APPLIED. IN THE STATISTICAL ANALYSIS OF THE UMBILICAL WOUND 1-WEEK POST PROCEDURE, INFECTION WAS RATED 1.33 AND 1.67 IN A VISUAL ANALOGUE BY THE OBSERVER AND THE PATIENT IN SUTURE GROUP, RESPECTIVELY; AND BLEEDING WAS RATED 1.56 IN A VISUAL ANALOGUE BY THE PATIENT IN SUTURE GROUP. PATIENTS' SATISFACTION POST PROCEDURE DID NOT SEEM TO RELATE TO THE PRESENCE OR ABSENCE OF SUTURES. LAPAROSCOPIC TROCAR SKIN INCISIONS, WHICH HAVE HAEMOSTASIS AT THE TIME OF OPERATION, DO NOT REQUIRE SKIN SUTURES EITHER FOR CLINICAL OR COSMETIC BENEFIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299731 UNKNOWN VICRYL RAPIDE SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention