BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 7926346 · Received October 2, 2018

    Report

    Report Number
    2210968-2018-76208
    Event Type
    Injury
    Date Received
    October 2, 2018
    Report Date
    September 4, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    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 OBTAIN 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 ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? CITATION: SURG TODAY. 2015; 45: 429¿433. DOI: 10.1007/S00595-014-0907-3. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: "PROSPECTIVE RANDOMIZED EVALUATION OF OPEN PREPERITONEAL VERSUS PREAPONEUROTIC PRIMARY ELECTIVE MESH REPAIR FOR PARAUMBILICAL HERNIAS," AUTHORS: MOHAMMAD HAMDY ABO-RYIA, OSAMA HELMY EL-KHADRAWY, GAMAL IBRAHIM MOUSSA, AHMAD MOHAMMAD SALEH. CITATION: SURG TODAY. 2015; 45: 429¿433. DOI: 10.1007/S00595-014-0907-3. THE AIM OF THIS STUDY WAS TO COMPARE THE PREPERITONEAL VERSUS THE PREAPONEUROTIC MESH POSITIONING IN OPEN PARAUMBILICAL HERNIA REPAIR. DURING THE PERIOD FROM JANUARY 2011 UNTIL JULY 2012, 60 ADULT PATIENTS (49 FEMALE AND 11 MALE PATIENTS) WERE RANDOMLY ASSIGNED TO 2 EQUAL GROUPS. THE PATIENTS IN GROUP A (N-30; MEAN AGE: 46.80 ± 12.12; BMI: 29.74 ± 3.23) WERE TREATED BY PRE-PERITONEAL MESH REPAIR AND THOSE IN GROUP B (N-30; MEAN AGE: 48.33 ± 12.34; BMI: 29.90 ± 3.18) UNDERWENT PRE-APONEUROTIC MESH REPAIR. DURING THE SURGICAL PROCEDURE IN GROUP A, PROLENE MESH (ETHICON) WAS INSERTED AND SPREAD IN THE SPACE THAT WAS CREATED, AND THE DEFECT WAS CLOSED BY PROLENE 0 SUTURES (ETHICON), TAKING BITES THROUGH THE MESH CENTER TO AVOID ITS DISLOCATION. THE UMBILICUS WAS REPOSITIONED BY VICRYL 2-0 SUTURES (ETHICON). THE SUBCUTANEOUS TISSUE WAS CLOSED BY INTERRUPTED VICRYL 2-0 SUTURES (ETHICON), AND THE SKIN WAS CLOSED WITH SUBCUTANEOUS PROLENE 3-0 SUTURES (ETHICON). DURING THE SURGICAL PROCEDURE IN GROUP B, AFTER THE DISSECTION AND REDUCTION OF THE HERNIA, THE DEFECT WAS CLOSED BY PROLENE 0 SUTURES (ETHICON), AND THE SUBCUTANEOUS TISSUE WAS DISSECTED TO EXPOSE THE APONEUROSIS FOR 5¿6 CM ALL AROUND THE EDGE OF THE DEFECT, THEN THE PROLENE MESH (ETHICON) WAS FIXED BY PROLENE 2-0 SUTURES (ETHICON) BOTH CIRCUMFERENTIALLY AND CENTRALLY. A CLOSED SUCTION DRAIN WAS THEN INSERTED, AND THE UMBILICUS WAS REPOSITIONED USING VICRYL 2-0 SUTURES (ETHICON). IN GROUP A, REPORTED COMPLICATIONS INCLUDED SUPERFICIAL WOUND INFECTION (N-2) AND HEMATOMA (N-2). IN GROUP B, REPORTED COMPLICATIONS INCLUDED SUPERFICIAL WOUND INFECTION (N-3), HEMATOMA (N-2), AND SEROMA FORMATION (N-5). THE PREPERITONEAL MESH PLACEMENT DURING THE REPAIR OF PARAUMBILICAL HERNIAS IS SUPERIOR TO THE PREAPONEUROTIC PLACEMENT, BECAUSE IT IS ASSOCIATED WITH FEWER COMPLICATIONS, LESS PAIN, AND A SHORTER TIME OF RETURN TO NORMAL DAILY ACTIVITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766886 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention VICRYL SUTURE, PROLENE SUTURE