BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 19035087 · Received April 3, 2024

    Report

    Report Number
    2210968-2024-03816
    Event Type
    Injury
    Date Received
    April 3, 2024
    Date of Event
    January 26, 2022
    Report Date
    April 3, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION: H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. THIS COMPLAINT WAS IDENTIFIED THROUGH THE CLINICAL EVALUATION REPORT (CER) PROCESS. THE CER PROCESS IS CONDUCTING A RETROSPECTIVE LITERATURE REVIEW FOR THE LIFE OF THE PRODUCT AND IN SOME CASES IDENTIFYING COMPLAINTS IN ARTICLES THAT CANNOT BE REASONABLY INVESTIGATED DUE TO THE AGE OF THE ARTICLE. ADDITIONALLY, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. NO PRODUCT AVAILABLE FOR RETURN. CITATIONS : BJS. VOL.109 (5):426¿432. HTTPS://DOI.ORG/10.1093/BJS/ZNAC053. NOTE: EVENTS REPORTED ON MW# 2210968-2024-03815, MW# 2210968-2024-03816. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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.

    Description of Event or Problem · 0

    TITLE : EXTENDED-COURSE ANTIBIOTIC PROPHYLAXIS IN LOWER LIMB AMPUTATION: RANDOMIZED CLINICAL TRIAL THE AIM OF THIS STUDY WAS TO EVALUATE WHETHER A 5-DAY VERSUS A 24-H COURSE OF ANTIBIOTIC PROPHYLAXIS REDUCED SSI IN PATIENTS UNDERGOING LLA. SOME 208 PATIENTS WERE SCREENED FOR ELIGIBILITY, OF WHOM 161 WERE RECRUITED AND RANDOMIZED BETWEEN 17 OCTOBER 2013 AND 12 DECEMBER 2015 (FIG. 1 AND TABLE 1). A TOTAL OF 152 PATIENTS WERE INCLUDED IN THE FINAL ANALYSIS. ALL PATIENTS NOT INCLUDED IN THE FINAL ANALYSIS DIED BEFORE THE DAY-30 POSTOPERATIVE PRIMARY ENDPOINT. ALL PATIENTS COMPLETED THE ANTIBIOTIC COURSE IN ACCORDANCE WITH THE PROTOCOL ALLOCATION (100 PER CENT COMPLIANCE). ®ALL WOUNDS WERE CLOSED IN LAYERS WITH ONE VICRYL® SUTURE TO THE DEEPER MUSCULOFASCIAL COMPARTMENTS, 2/0 VICRYL TO SUPERFICIAL®FASCIA, AND 3/0 MONOCRYL SUTURE TO THE SKIN. STERI-STRIPS¿ WERE APPLIED, AND A NON-ADHERENT CONTACT DRESSING, GAUZE, AND WOOL AND CREPE BANDAGE WERE USED TO DRESS THE WOUND. THE REPORTED COMPLICATIONS INCLUDED SURGICAL SITE INFECTION (N=39) AND IMPAIRED WOUND HEALING (N=61). IN CONCLUSION, SSI AND IWH ARE COMMON AFTER LLA AND HAVE A SIGNIFICANT IMPACT ON OUTCOME. A 5-DAY COURSE OF ANTIBIOTIC PROPHYLAXIS WAS ASSOCIATED WITH A REDUCTION IN BOTH SSI AND IWH COMPARED WITH A 24-H COURSE, AND THIS REDUCED THE NEED FOR FURTHER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1624510 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention