BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 20529881 · Received October 24, 2024

    Report

    Report Number
    2210968-2024-11080
    Event Type
    Injury
    Date Received
    October 24, 2024
    Date of Event
    December 29, 2023
    Report Date
    October 24, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: CHIRURGIE. HTTPS://DOI.ORG/10.1007/S00104-023-02010-9.

    Description of Event or Problem · 0

    TITLE: COMPARISON BETWEEN STAPLED HEMORRHOIDOPEXY AND HARMONIC SCALPEL HEMORRHOIDECTOMY IN THE MANAGEMENT OF THIRD- AND FOURTH-DEGREE PILES: A RANDOMIZED CLINICAL TRIAL THE AIM OF THIS STUDY WAS TO COMPARE THE RESULTS OF STAPLED HEMORRHOIDOPEXY (SH) AND HARMONIC SCALPEL HEMORRHOIDECTOMY (HSH) IN THE MANAGEMENT OF GRADE III AND GRADE IV PILES REGARDING THE TIME OF THE PROCEDURE, POSTOPERATIVE PAIN, PATIENT SATISFACTION, WOUND INFECTION, BLEEDING, INCONTINENCE, AND RECURRENCE WITHIN 1 YEAR. THIS WAS A SINGLE-BLIND, PROSPECTIVE, RANDOMIZED, CONTROLLED, SINGLE-CENTER TRIAL CONDUCTED FROM (B)(6) TO (B)(6) 2022 THAT INCLUDED A TOTAL OF (B)(4) WITH THIRD- AND FOURTH-DEGREE PILES. THE PATIENTS WERE DIVIDED INTO TWO GROUPS OF (B)(4) PATIENTS EACH. GROUP I UNDERWENT SH AND GROUP II UNDERWENT HSH. THE MEAN AGE OF GROUP I WAS 42.94 YEARS AND OF GROUP II, 42.20 YEARS. GROUP I UNDERWENT STAPLER HEMORRHOIDECTOMY USING THE EXTERNAL DEVICE (TRANSPARENTANOSCOPE) OF A PPH STAPLER (PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER SET; (B)(4), RARITAN, (B)(6), USA). HEMOSTASIS ALONG THE STAPLE LINE WAS ACHIEVED, AND IF REQUIRED, A 3-0 VICRYL SUTURE WAS USED IN THE CASE OF BLEEDING. IN GROUP II, THE PROCEDURE WAS PERFORMED USING THE HARMONIC BLADES (ETHICON ENDO-SURGERY INC., (B)(6), OH, USA). REPORTED COMPLICATIONS IN GROUP I INCLUDE PAIN (MILD AND MODERATE) AT FIRST 2 WEEKS AND AFTER 2 WEEKS, WOUND INFECTION, AND POSTOPERATIVE BLEEDING. IN CONCLUSION, COMPARED WITH SH, HSH WAS SAFER, EASIER, AND ASSOCIATED WITH A LOWER INCIDENCE OF RECURRENCE AFTER 1 YEAR AND WITH HIGHER PATIENT SATISFACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890574 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other