BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSIOMESH UNKNOWN PRODUCT

    MDR report key: 11709680 · Received April 22, 2021

    Report

    Report Number
    2210968-2021-03661
    Event Type
    Injury
    Date Received
    April 22, 2021
    Date of Event
    February 27, 2020
    Report Date
    March 25, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K093932
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 05/31/2021. 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. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? IF SO, PLEASE SPECIFY. 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?

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). ATTEMPTS ARE BEING MADE TO CLARIFY 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? IF SO, PLEASE SPECIFY. 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? (B)(4). 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION:WORLD J SURG (2020) 44:2394¿2400 HTTPS://DOI.ORG/10.1007/S00268-020-05436-Y. RELATED MEDWATCH REPORTS: 2210968-2021-03658, 2210968-2021-03660.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE: TITLE: MESH REPAIR IN CROHN¿S DISEASE: A CASE-MATCHED MULTICENTER STUDY IN 234 PATIENTS. AUTHORS: LAURA BEYER-BERJOT, DAVID MOSZKOWICZ, VALE´RIE BRIDOUX, LUCIL SCHNEIDER, LUCA THEUIL, YVES FRANC¸OIS, SOLAFAH ABDALLA, EDDY COTTE, LE´ON MAGGIORI, ANTOINE BROUQUET, FRANC¸OIS-RE´GIS SOUCHE, PHILIPPE ZERBIB, JEAN-JACQUES TUECH, YVES PANIS, STE´PHANE BERDAH. CITATION:WORLD J SURG (2020) 44:2394¿2400 HTTPS://DOI.ORG/10.1007/S00268-020-05436-Y. THIS IS A RETROSPECTIVE MULTICENTRE STUDY COMPARING CD AND NON-CD PATIENTS UNDERGOING MESH REPAIR FOR VENTRAL HERNIA (PRIMARY OR INCISIONAL HERNIA). A TOTAL OF 234 PATIENTS ,114 IN CROHN¿S DISEASE(CD) GROUP AND 120 IN CONTROL GROUP WERE INCLUDED. SYNTHETIC MESHS PROLENE(ETHICON), PROCEED (ETHICON) AND PHYSIOMESH(ETHICON) WERE UTILIZED. MESH COULD BE POSITIONED AS IPOM OR SUBLAY (I.E., RETRO-RECTUS) BY A LAPAROSCOPIC OR OPEN APPROACH. ALL TYPES OF VH REPAIR WERE INCLUDED, PROVIDED THAT THEY INVOLVED MESH POSITIONING. ALL TYPES OF MESH WERE INCLUDED (ABSORBABLE, PERMANENT SYNTHETIC OR BIOLOGICAL) ALONG WITH ALL MEANS OF MESH FIXATION (THREADS OR TACKERS). MESH COULD BE POSITIONED AS IPOM OR SUBLAY (I.E., RETRO-RECTUS) BY A LAPAROSCOPIC OR OPEN APPROACH. REPORTED COMPLICATIONS INCLUDED IN CD GROUP OVERALL ABDOMINAL SEPTIC MORBIDITY (N=21), SHORT-TERM ABDOMINAL SEPTIC MORBIDITY (N=11), LONG-TERM ABDOMINAL SEPTIC MORBIDITY (N=13), MESH WITHDRAWAL (N=6) ,ENTERO-PROSTHETIC FISTULA (N=8) , HERNIA RECURRENCE (N=16). IN CONTROL GROUP OVERALL ABDOMINAL SEPTIC MORBIDITY (N=6), SHORT-TERM ABDOMINAL SEPTIC MORBIDITY (N=3), LONG-TERM ABDOMINAL SEPTIC MORBIDITY (N=2),HERNIA RECURRENCE (N=10). IN CONCLUSION, CD IS A RISK FACTOR FOR SEPTIC MORBIDITY AFTER MESH REPAIR IN VH, AND THIS RISK SHOULD BE WELL EXPLAINED TO THE CD PATIENTS NEEDING HERNIA REPAIR. MOREOVER, FORTHCOMING STUDIES SHOULD ASSESS SLOW ABSORBABLE MESH REPAIR AND THE WW STRATEGY IN THE SPECIFIC CASE OF UNCOMPLICATED VH IN THE CD POPULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603678 PHYSIOMESH UNKNOWN PRODUCT MESH, SURGICAL FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention