BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 11712858 · Received April 23, 2021

    Report

    Report Number
    2210968-2021-03675
    Event Type
    Death
    Date Received
    April 23, 2021
    Date of Event
    October 5, 2017
    Report Date
    March 26, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Removal / Correction Number
    N/A
    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. 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT THE ETHICON PRODUCT (SOFT PROLENE MESH) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? PATIENT DEMOGRAPHICS? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT (SOFT PROLENE MESH) USED IN THIS PROCEDURE? WHAT IS THE CAUSE OF DEATH IN THE PATIENT WHO EXPIRED FOLLOWING THE MANAGEMENT OF THE LEAKAGE OF HIS LARGE BOWEL COLONIC ANASTOMOSIS, AND IS THE DEATH RELATED TO THE USE OF THE SOFT PROLENE MESH STRIPS? WOULD THE SURGEON LIKE TO SPEAK WITH ETHICON MEDICAL SAFETY AND ENGINEERING VIA A SCHEDULED CONFERENCE CALL REGARDING THE PRODUCT INVOLVED IN THIS EVENT? CITATION: THE AMERICAN JOURNAL OF SURGERY 216 (2018) 267E273. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. DEATH EVENT WAS SUBMITTED VIA 2210968-2021-03675 OTHER ADVERSE EVENTS WERE SUBMITTED VIA 2210968-2021-03676.

    Description of Event or Problem · 1

    TITLE: MESH SUTURED REPAIRS OF CONTAMINATED INCISIONAL HERNIAS WE SOUGHT TO EVALUATE THE RESULTS OF A NEW MESH SUTURED REPAIR TECHNIQUE FOR CLOSURE OF CONTAMINATED INCISIONAL HERNIAS. BETWEEN NOV 2013 AND FEBRUARY 2017, THERE WERE 48 PATIENTS WITH CONTAMINATED HERNIAS 5 CM WIDE OR GREATER BY CT SCAN WERE CLOSED WITH MESH SUTURES USING A POLYPROPYLENE MESH (PROLENE® SOFT PROLENE MESH, ETHICON, (B)(6)). THERE WERE 16 MEN AND 32 WOMEN, WITH A MEAN AGE OF 62 (RANGE 14E84) AND AN AVERAGE BMI OF 29.8. THE PATIENT HAD AN UNEXPECTED RETURN TO THE OPERATING ROOM WITHIN 30 DAYS FOR COMPLICATIONS RELATED TO THE INTRA-ABDOMINAL PROCEDURE FOR LEAKAGE OF HIS LARGE BOWEL COLONIC ANASTOMOSIS. THE PATIENT, IN EXTREMIS, WAS CLOSED WITH A RUNNING STANDARD SUTURE. THIS LATTER PATIENT EXPIRED THE FOLLOWING DAY. MESH SUTURED CLOSURE REPRESENTS A SIMPLIFIED AND EFFECTIVE SURGICAL STRATEGY FOR CONTAMINATED MIDLINE INCISIONAL HERNIA REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617002 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R