BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 14434427 · Received May 19, 2022

    Report

    Report Number
    2210968-2022-03846
    Event Type
    Injury
    Date Received
    May 19, 2022
    Date of Event
    June 22, 2021
    Report Date
    May 20, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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? 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. 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. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: LANGENBECK¿S ARCHIVES OF SURGERY (2021) 406:2861¿2867, HTTPS://DOI.ORG/10.1007/S00423-021-02227-4.

    Description of Event or Problem · 0

    TITLE: ANOCUTANEOUS ADVANCEMENT FLAP PROVIDES A QUICKER CURE THAN FISSURECTOMY IN SURGICAL TREATMENT FOR CHRONIC ANAL FISSURE¿A RETROSPECTIVE, OBSERVATIONAL STUDY. THIS STUDY AIMED TO ASSESS THE RESULTS OF ANOCUTANEOUS ADVANCEMENT FLAP IN A CONSECUTIVE COHORT OF PATIENTS. FROM 2000 TO 2011, 481 PATIENTS OPERATED ON FOR A SINGLE CHRONIC ANAL FISSURE WERE INCLUDED IN THE STUDY. THERE WERE 223 MALES AND 258 FEMALES WITH A MEAN AGE OF 42.6 YEARS (RANGE 19.8-87.0). ANOCUTANEOUS ADVANCEMENT FLAP WAS PERFORMED IN 455 AND FISSURECTOMY IN 26 OF THE PATIENTS. DURING THE ANOCUTANEOUS ADVANCEMENT FLAP PROCEDURE, THE SKIN FLAP WAS TRANSFERRED TENSION-FREE INTO THE ANAL CANAL AND SUTURED TO THE RECTAL MUCOSA WITH TWO CONTINUOUS MONOFIL SUTURES OF 3¿0 MONOCRYL (ETHICON). NO WOUND CLOSURE WITH A FLAP WAS PERFORMED AFTER FISSURECTOMY IN PATIENTS WHEN A TENSION-FREE FLAP COULD NOT BE RAISED DUE TO LACK OF SUFFICIENT SKIN MATERIAL. PATIENTS WITH ANOCUTANEOUS ADVANCEMENT FLAP AND WITH FISSURECTOMY WERE ADVISED TO PRESENT POSTOPERATIVELY FOR A ROUTINE FOLLOW-UP 1 MONTH AFTER SURGERY AND LATER IN ANY CASE OF POSTOPERATIVE COMPLICATION OR RECURRENCE. COMPLICATIONS INCLUDE ANAL ABSCESS (N=1), ANAL ABSCESS AND FISTULA (N=13), HEMORRHOIDAL PROLAPSE (N=1), WOUND DEHISCENCE (N=1), POSTOPERATIVE ANAL INCONTINENCE (N=1), AND WOUND NOT HEALED (N=14). IN CONCLUSION, ANOCUTANEOUS ADVANCEMENT FLAP IS A VERY SAFE SPHINCTER-SPARING SURGICAL OPTION FOR CHRONIC ANAL FISSURE, PROVIDES A QUICKER CURE THAN FISSURECTOMY, AND MAY BE CONSIDERED A GOOD FIRST-LINE SURGICAL TREATMENT OPTION FOR CHRONIC ANAL FISSURES IF MEDICAL TREATMENT FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1976981 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention