BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT

    MDR report key: 15353021 · Received September 2, 2022

    Report

    Report Number
    2210968-2022-07276
    Event Type
    Injury
    Date Received
    September 2, 2022
    Date of Event
    February 4, 2021
    Report Date
    September 2, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K810428
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. COMPONENT CODE: (B)(4) -- DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2022-07276. CITATION CITE: LANGENBECK'S ARCHIVES OF SURGERY (2021) 406:1591¿1598 HTTPS://DOI.ORG/10.1007/S00423-021-02091-2.

    Description of Event or Problem · 0

    IS IT POSSIBLE TO REDUCE RECURRENCES AFTER ALTEMEIER¿S PROCEDURE FOR COMPLETE RECTAL PROLAPSE TWENTY-YEAR EXPERIENCE IN 130 CONSECUTIVE PATIENTS? THE PRESENT RETROSPECTIVE STUDY REPORTS THE LONG-TERM RESULTS OF ALTEMEIER¿S OPERATION WITH LEVATORPLASTY AND THE SAME PROCEDURE ASSOCIATED WITH TOCS, IN A LARGE SERIES OF PATIENTS WITH CPR. MEDICAL RECORDS OF 110 PATIENTS UNDERGOING ALTEMEIER WITH LEVATORPLASTY (GROUP 1) AND 20 PATIENTS SUBMITTED TO THE SAME PROCEDURE ASSOCIATED WITH TOCS (GROUP 2) FOR NEWLY DIAGNOSED COMPLETE RECTAL PROLAPSE WERE REVIEWED. ALL PATIENTS HAD BEEN RECRUITED AFTER PREOPERATIVE CLINICAL EXAMINATION, SF-36 QUALITY OF LIFE, CONTINENCE SCORE AND COLONOSCOPY. ULTRACISION HARMONIC SCALPEL G 300 AND COAGULATING SHEARS 14C (ETHICON ENDO-SURGERY, INC., CINCINNATI, OHIO) TO ACHIEVE A TISSUE DISSECTION WITHOUT THE NEED OF VESSEL LIGATURES. ANASTOMOSIS BETWEEN THE UPPER COLON AND THE DIVIDED ANAL RING WAS PERFORMED MANUALLY, WITH INTERRUPTED 3/0 VICRYL SUTURES, OR MECHANICALLY, WITH DIFFERENT CIRCULAR STAPLERS, DEPENDING ON THE SIZE OF THE DESCENDING COLON. ASSOCIATED TRANS-OBTURATOR TAPING(TVT-O) WAS PERFORMED DURING THE ALTEMEIER¿S PROCEDURE, AFTER THE PREPARATION AND BEFORE THE RESECTION OF THE PROLAPSED BOWEL. VYCRIL MESH WAS ALSO USED DURING THE REDO-ALTEMEIER. REPORTED COMPLICATIONS INCLUDED ANASTOMOTIC DEHISCENCE, PAIN, PERINEAL ABSCESSES, URINARY RETENTION, ANAL STRICTURES, RECTAL DYSCHEZIA, TENESMUS , RECTAL BLEEDING, RECURRENCE IN CONCLUSION WITH ALL THE LIMITATIONS OF A RETROSPECTIVE STUDY, THE CLINICAL AND FUNCTIONAL RESULTS OF OUR 20-YEAR EXPERIENCE WITH THE ALTEMEIER¿S PROCEDURE IN 130 PATIENTS INDICATE THAT THE PROCEDURE IS SAFE AND EFFECTIVE FOR THE TREATMENT OF CRP, EVEN IF LIMITED BY THE NON-NEGLIGIBLE INCIDENCE OF ANASTOMOTIC COMPLICATIONS AND RECURRENCE RATE. THE COMBINATION OF ALTEMEIER WITH TOCS SHOWED A POSITIVE TREND TO A REDUCTION OF THE RECURRENCE RATE, NOT WORSENING MORBIDITY AND OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2500773 VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention