BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 11712882 · Received April 23, 2021

    Report

    Report Number
    2210968-2021-03676
    Event Type
    Injury
    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

    PRODUCT COMPLAINT: (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. 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. DEATH EVENT WAS SUBMITTED VIA 2210968-2021-03675.

    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)(4)). THERE WERE 16 MEN AND 32 WOMEN, WITH A MEAN AGE OF 62 (RANGE 14-84) AND AN AVERAGE BMI OF 29.8. THREE CASES HAD AN UNEXPECTED RETURN TO THE OPERATING ROOM WITHIN 30 DAYS THAT DIRECTLY ATTRIBUTABLE TO THE ABDOMINAL WALL CLOSURE, WITH 1 SUBCUTANEOUS HEMATOMA AND 2 INFECTED FLUID COLLECTIONS BEING MANAGED OPERATIVELY WITH WASH-OUTS. THESE THREE PATIENTS DID NOT REQUIRE REVISION OF THE ABDOMINAL WALL CLOSURE AND THE STRIPS WERE LEFT IN PLACE. TWO PATIENTS HAD AN UNEXPECTED RETURN TO THE OPERATING ROOM WITHIN 30 DAYS FOR COMPLICATIONS RELATED TO THE INTRA-ABDOMINAL PROCEDURE, ONE FOR MANAGEMENT OF A SMALL BOWEL LEAK AFTER ENTEROENTEROSTOMY AND THE OTHER FOR LEAKAGE OF HIS LARGE BOWEL COLONIC ANASTOMOSIS. ONE WAS RECLOSED WITH NEW MESH STRIPS. THREE PATIENTS WERE READMITTED WITHIN 30 DAYS THOUGH ONLY ONE FOR THE ABDOMINAL WALL CLOSURE DUE TO A SUPERFICIAL CELLULITIS TREATED WITH IV ANTIBIOTICS. THE REMAINING TWO PATIENTS HAD ISSUES OF HYPONATREMIA AND A URINOMA. 7 PATIENTS HAD SUPERFICIAL INFECTIONS, 3 PATIENTS HAD DEEP SSI. WHILE TWO SUPERFICIAL INFECTIONS WERE TREATED IN THE OPERATING ROOM WITH SOFT TISSUE IRRIGATION AND DEBRIDEMENT, THE OTHER 5 SUPERFICIAL SSI PATIENTS HEALED WITH CONSERVATIVE MANAGEMENT THAT CONSISTED OF LOCAL WOUND CARE AND ORAL ANTIBIOTICS. 1 PATIENT HAD HEMATOMA AND 1 PATIENT HAD A SKIN OPENING THAT RESOLVED WITH DRESSING CHANGES. ONE KNOT WAS REMOVED AFTER DRAINAGE OF A SUBCUTANEOUS ABSCESS, AND ONE KNOT FOUND AT THE BOTTOM OF A SEROMA CAVITY WAS SIMILARLY EXCISED. THE ¿BODY¿ OF THESE TWO SUTURES REMAINED IN THE ABDOMINAL WALL. 1 FEMALE PATIENT WITH A MASSIVE CONTAMINATED HERNIA AND LOSS OF DOMAIN HAD PARTIAL ABDOMINAL WALL APPROXIMATION WITH MESH STRIPS, FOLLOWED BY TWO ADDITIONAL TRIPS TO THE OPERATING ROOM FOR SERIAL STAGED CLOSURES. HER SKIN WAS LEFT OPEN TO GRANULATE CLOSED. AT 4 MONTHS, TWO EXPOSED KNOTS WERE REMOVED AT BEDSIDE. FOLLOW-UP AT 16 MONTHS SHOWED A CLINICALLY INTACT ABDOMINAL WALL. 3 PATIENTS DEVELOPED A HERNIA RECURRENCE AT THEIR MIDLINE CLOSURE WITH A MEAN FOLLOW UP OF 358 DAYS 3 PATIENTS HAD PARASTOMAL RECURRENCES. 2 PATIENTS HAVE HAD A REPEAT HERNIA REPAIR WITH A PLANAR MESH, AND THE REOPERATIVE DISSECTION WAS NOT UNUSUAL IN ANY WAY. BIOPSIES OF THE MESH SUTURES SHOWED A MILD CHRONIC FOREIGN BODY REACTION BY PATHOLOGY. 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
    609854 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention