BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED MESH

    MDR report key: 8859221 · Received August 5, 2019

    Report

    Report Number
    2210968-2019-85129
    Event Type
    Injury
    Date Received
    August 5, 2019
    Report Date
    July 8, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K060713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4).

    Additional Manufacturer Narrative · 1

    (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: SURG ENDOSC (2010) 24:3002¿3007 / DOI 10.1007/S00464-010-1076-0. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: PROSPECTIVE EVALUATION OF ADHESION CHARACTERISTICS. TO INTRAPERITONEAL MESH AND ADHESIOLYSIS-RELATED COMPLICATIONS DURING LAPAROSCOPIC RE-EXPLORATION AFTER PRIOR VENTRAL HERNIA REPAIR. THE PURPOSE OF THIS PROSPECTIVE STUDY WAS TO CHARACTERIZE THE ADHESION CHARACTERISTICS OF ABSORBABLE- AND NONABSORBABLE-BARRIER-COATED MESHES AND TO REPORT ADHESIOLYSIS-RELATED COMPLICATIONS DURING LAPAROSCOPIC RE-EXPLORATION AFTER PRIOR VENTRAL HERNIA REPAIR. FROM MAY 2006 TO MAR 2009, A TOTAL OF 69 PATIENTS [N=21 MALE, N=48 FEMALE, MEAN AGE 52.8 YEARS (RANGE 26-78 YEARS) UNDERWENT A LAPAROSCOPIC RE-INTERVENTION AFTER PRIOR INTRAPERITONEAL MESH PLACEMENT FOR VENTRAL HERNIA REPAIR (VHR). THE PATIENTS WERE DIVIDED INTO FIVE GROUPS DEPENDING ON THE INTRAPERITONEAL MESHES PLACED: PERMANENT-BARRIER NON-COMPOSITE MESH (N=14); PERMANENT-BARRIER COMPOSITE MESH (N=17); ABSORBABLE-BARRIER-COATED MESH (N=18); UNCOATED POLYPROPYLENE MESH (N=12); AND BIOLOGIC MESH (N=8). IN THE ABSORBABLE-BARRIER-COATED MESH GROUP, THE PATIENTS WERE FURTHER DIVIDED BASED ON BRAND OF MESH USED: PROCEED (N=8); C-QUR (N=5); SEPRA-MESH (N=4); AND PARIETEX COMPOSITE (N=1) DURING LAPAROSCOPIC RE-EXPLORATION. POSTOPERATIVE COMPLICATIONS INCLUDED RECURRENT HERNIA (N=13) AND SMALL INTESTINE/COLON ADHERENT TO MESH (N=12). ADHESION CHARACTERISTICS OF ABSORBABLE-BARRIER-COATED MESHES AND NONABSORBABLE COMPOSITE AND NON-COMPOSITE MESHES AND ADHESIOLYSIS-RELATED COMPLICATIONS DURING LAPAROSCOPIC RE-EXPLORATION AFTER VENTRAL HERNIA REPAIR ARE ASSOCIATED WITH THE UNIQUE PROPERTIES OF THE BARRIER AND/OR MESH. THE POTENTIAL MORBIDITY OF A LAPAROSCOPIC RE-EXPLORATION AFTER INTRAPERITONEAL MESH PLACEMENT SHOULD BE CONSIDERED IN OPERATIVE PLANNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653140 PROCEED MESH MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention