BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE HERNIA SYSTEM UNKNOWN PRODUCT

    MDR report key: 8426492 · Received March 16, 2019

    Report

    Report Number
    2210968-2019-79527
    Event Type
    Injury
    Date Received
    March 16, 2019
    Report Date
    February 22, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K984220
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    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. CITATION: HERNIA (2008) 12:437¿440; DOI 10.1007/S10029-008-0338-4. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: BOWEL COMPLICATIONS AFTER PROLENE HERNIA SYSTEM (PHS) REPAIR: A CASE REPORT AND REVIEW OF THE LITERATURE". AUTHOR(S): D. J. LO · K. Y. BILIMORIA · C. M. PUGH. CITATION: HERNIA (2008) 12:437¿440; DOI 10.1007/S10029-008-0338-4. THIS CASE AIMED TO PRESENT A (B)(6)-YEAR-OLD MALE PATIENT WHO UNDERWENT LEFT INGUINAL HERNIA REPAIR USING A PROLENE HERNIA SYSTEM (PHS) DEVICE 18 MONTHS PRIOR. 2-0 PROLENE SUTURES HAD BEEN USED TO ANCHOR THE MESH DEVICE AT THE PUBIC TUBERCLE AND TRANSVERSALIS FASCIA. THIS PATIENT PRESENTED WITH CRAMPY ABDOMINAL PAIN, NAUSEA, VOMITING, ANOREXIA, BILIOUS EMESIS AND OBSTIPATION. HE HAD TENDERNESS IN THE MIDEPIGASTRIC AREA, LEFT LOWER QUADRANT, AND AT THE SITE OF HIS PREVIOUS LEFT INGUINAL HERNIA REPAIR. FURTHER EXAMINATION REVEALED SMALL BOWEL OBSTRUCTION IN WHICH MESH FROM THE LEFT INGUINAL HERNIA WAS ADHERENT TO THE SMALL BOWEL AND APPENDICES EPIPLOICA OF THE SIGMOID COLON. THE ADHESIONS BETWEEN THE SMALL BOWEL, SIGMOID COLON AND MESH WERE TAKEN DOWN, AND THE BOWEL WAS DISSECTED FREE FROM THE MESH. THE EVIDENCE OF SMALL BOWEL PERFORATION WAS SEALED. THE SEGMENT OF THE BOWEL, WHICH WAS ADHERENT TO THE MESH, WAS RESECTED AND A PRIMARY ANASTOMOSIS WAS PERFORMED. THE PATIENT HAD AN UNEVENTFUL RECOVERY. IN THE YEAR AFTER HIS SURGERY, THERE HAS BEEN NO EVIDENCE OF MESH INFECTION. THE PLACEMENT OF THE UNDERLAY COMPONENT REQUIRES BLIND DISSECTION AND PATCH DEPLOYMENT WITHIN THE PREPERITONEAL SPACE. DURING THE INITIAL SURGERY, THE PERITONEAL CAVITY MAY HAVE BEEN VIOLATED INADVERTENTLY DURING THE BLIND DISSECTION OR THERE MAY HAVE BEEN AN EXISTING DEFECT IN THE HERNIA SAC, LEADING TO INTRAPERITONEAL PLACEMENT OF THE MESH. SECONDLY, THE UNDERLAY PATCH MAY HAVE BEEN DEPLOYED IMPROPERLY, AND SINCE IT WAS NOT FIXED WITH SUTURES, PART OR ALL OF IT MAY HAVE MIGRATED INTO THE PERITONEAL CAVITY. LASTLY, THE UNDERLAY PATCH SIMPLY MAY HAVE BEEN PLACED TOO DEEP WITHIN THE INGUINAL CANAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219692 PROLENE HERNIA SYSTEM UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention