BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 19059050 · Received April 8, 2024

    Report

    Report Number
    2210968-2024-03983
    Event Type
    Injury
    Date Received
    April 8, 2024
    Date of Event
    March 7, 2022
    Report Date
    April 8, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 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. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: ANN COLOPROCTOL 2022 MAR 7; HTTPS://DOI.ORG/10.3393/AC.2021.00682.0097.

    Description of Event or Problem · 0

    TITLE: COMPARISON OF BLOWHOLE COLOSTOMY AND LOOP OSTOMY FOR PALLIATION OF ACUTE MALIGNANT COLONIC OBSTRUCTION. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO COMPARE THE SURGICAL RESULTS OF BLOWHOLE COLOSTOMY AND LOOP OSTOMY IN TERMINAL CANCER PATIENTS WITH URGENT OR EMERGENT COMPLETE COLONIC OBSTRUCTION. BETWEEN JANUARY 2011 TO OCTOBER 2020, A TOTAL OF 59 PATIENTS (33 MALE AND 26 FEMALE; MEAN AGE WAS 68.83±12.45 YEARS) WHO UNDERWENT COLOSTOMY OR ILEOSTOMY DUE TO COMPLETE COLONIC OBSTRUCTION WERE INCLUDED IN THE STUDY. THE PATIENTS WERE DIVIDED INTO 2 GROUPS: BLOWHOLE COLOSTOMY GROUP (N=24) OR LOOP OSTOMY GROUP (N=35). A 4-0 VICRYL SUTURE WAS USED IN PERFORMING BLOWHOLE COLOSTOMY. REPORTED COMPLICATIONS INCLUDE STOMA-RELATED COMPLICATIONS SUCH AS PARASTOMAL HERNIA (N=3), BLEEDING (N=1), AND DEHISCENCE (N=1); AND SEPSIS (N=1). IN CONCLUSION, IN SURGICAL EMERGENCIES, DIVERTING A BLOWHOLE COLOSTOMY CAN BE SAFE AND EFFECTIVE FOR PALLIATIVE MANAGEMENT OF COLONIC OBSTRUCTION IN PATIENTS WITH END-STAGE CANCER AND MIGHT REDUCE THE OPERATIVE TIME IN EMERGENT SITUATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120638 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention