BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 8897879 · Received August 15, 2019

    Report

    Report Number
    2210968-2019-85625
    Event Type
    Injury
    Date Received
    August 15, 2019
    Report Date
    July 17, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: BMJ CASE REPORTS 2012; DOI:10.1136/BCR.01.2012.5508. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: STOMACH IN A PARASTOMAL HERNIA: UNCOMMON PRESENTATION. THE PURPOSE OF THIS CASE REPORT IS TO DISCUSS THE PRESENCE OF STOMACH IN A PARASTOMAL HERNIA. THIS IS REGARDING A (B)(6) YEAR OLD LADY WHO PRESENTED WITH FREQUENT EARLY POSTPRANDIAL VOMITING DEVOID OF BILE, UPPER ABDOMINAL DISTENSION AND WEIGHT LOSS FOR THE PRECEDING 8 WEEKS. PATIENT¿S MEDICAL HISTORY INCLUDED CROHNS DISEASE, FOR WHICH SHE UNDERWENT A PANPROCTOCOLECTOMY AND END ILEOSTOMY IN 2002. SHE UNFORTUNATELY DEVELOPED RECURRENT PARASTOMAL HERNIAS, AND 6 MONTHS BEFORE ADMISSION HER PARASTOMAL HERNIA WAS ONCE AGAIN REPAIRED. ON EXAMINATION, HER ABDOMEN WAS SOFT WITH A PROMINENT TENDER PARASTOMAL HERNIA. BARIUM MEAL AND FOLLOW THROUGH REVEALED THAT THE STOMACH HAD HERNIATED THROUGH THE ABDOMINAL WALL AND WAS CAUSING GASTRIC OUTLET OBSTRUCTION. THE PATIENT UNDERWENT LAPAROTOMY AND WAS FOUND THAT SHE HAD A SUBCUTANEOUS INCARCERATED PARASTOMAL HERNIA CONTAINING VIABLE STOMACH AND SMALL BOWEL LOOPS. THE HERNIAL SAC CONTENTS WERE REDUCED BACK INTO THE PERITONEUM AND THE ABDOMINAL WALL DEFECT WAS REPAIRED USING THE OPEN SOMBRERO REPAIR TECHNIQUE WITH A 25/20 CM PARIETEX AND 6/11 CM WRAPPED PROLENE MESH. POSTOPERATIVE COMPLICATION INCLUDED PURULENT COLLECTIONS IN THE SUBCUTANEOUS PLANE AROUND THE MESH. THE PARIETEX MESH WAS REMOVED AND REPLACED WITH A PHYSIO MESH. THE PATIENT THEN MADE AN UNEVENTFUL RECOVERY AND WAS DISCHARGED 10 DAYS LATER. NO TECHNICAL FACTORS RELATED TO THE CONSTRUCTION OF THE STOMA HAVE BEEN SHOWN TO PREVENT HERNIATION. 2 CONTENTS OF HERNIA SAC MAY INCLUDE OMENTUM, SMALL BOWEL AND COLON. STOMACH MAY APPEAR IN THE PARASTOMAL HERNIA SAC VERY RARELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690382 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention