BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 8910848 · Received August 20, 2019

    Report

    Report Number
    2210968-2019-85804
    Event Type
    Death
    Date Received
    August 20, 2019
    Report Date
    July 25, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 1/22/2021. NO ADDITIONAL INFORMATION NEEDS TO BE REPORTED. THE FILE WAS REOPENED IN ERROR. HEALTH IMPACT CODE: F02 HAS BEEN ADDED TO RECLOSE THE FILE. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 1/22/2021.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). ALL OTHER EVENTS DESCRIBED IN JOURNAL ARTICLE ARE SUBMITTED IN MW # 2210968-2019-85805. 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: ANNALS OF SURGICAL INNOVATION AND RESEARCH. 2012, 6: 1. 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. DOES THE SURGEON BELIEVE THAT THE ETHICON PRODUCT (PROLENE MESH) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POSTOPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT (PROLENE MESH) USED IN THIS PROCEDURE? WOULD THE SURGEON LIKE TO SPEAK WITH ETHICON MEDICAL AND ENGINEERING? (TRANSLATION IS AVAILABLE). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: EMERGENCY INCISIONAL HERNIA REPAIR: A DIFFICULT PROBLEM WAITING FOR A SOLUTION. EMERGENCY REPAIR OF INCARCERATED INCISIONAL HERNIA WITH ASSOCIATED BOWEL OBSTRUCTION IN POTENTIALLY OR CONTAMINATED FIELD IS TECHNICALLY CHALLENGING DUE TO EDEMATOUS, INFLAMED AND FRIABLE TISSUES WITH OCCASIONAL NEED FOR CONCURRENT BOWEL RESECTION AND CARRIES HIGH RATES OF POST-OPERATIVE INFECTIOUS COMPLICATIONS. THE AIM OF THIS STUDY WAS TO RETROSPECTIVELY ASSESS THE WOUND RELATED MORBIDITY OF USE OF PERMANENT PROSTHETIC MESH IN EMERGENCY REPAIR OF INCARCERATED INCISIONAL HERNIA WITH ASSOCIATED BOWEL OBSTRUCTION. THE AUTHORS ALSO DESCRIBED A NEW TECHNIQUE OF LEAVING THE MESH EXPOSED TO HEAL BY SECONDARY INTENTION WITH GRANULATION TISSUE. BETWEEN 2000 AND 2010, A TOTAL OF 60 PATIENTS (9 MALE AND 51 FEMALE PATIENTS) UNDERWENT EMERGENCY SURGERY FOR INCARCERATED INCISIONAL HERNIA WITH ASSOCIATED BOWEL OBSTRUCTION WITH PLACEMENT OF PERMANENT PROSTHETIC MESH. THE AUTHORS DIVIDED THE PATIENTS INTO TWO GROUPS ON BASIS OF WOUND CLOSURE. IN ONE GROUP, A 90 GRAM PROLENE MESH (ETHICON) WAS FIXED OVER THE ANTERIOR RECTUS SHEATH AFTER PRIMARY REPAIR OF HERNIA (STANDARD ONLAY TECHNIQUE) AND THE WOUND WAS CLOSED IN LAYERS. IN OTHER GROUP, THE PROLENE MESH (ETHICON) WAS PLACED OVER THE PRIMARILY REPAIRED DEFECT BY ONLAY TECHNIQUE BUT THE WOUND WAS LEFT OPEN. A (B)(6) YEAR OLD FEMALE PATIENT WITH SEPTICEMIA AND DIED ON THE 5TH POST-OPERATIVE DAY. THE RETROSPECTIVE NATURE AND SMALL SAMPLE SIZE OF THIS STUDY LIMITS THE CONCLUSIONS THAT CAN BE DRAWN REGARDING THE RATIONALE FOR WHICH PROCEDURE SHOULD BE APPLIED TO EACH INDIVIDUAL PATIENT. FROM THE RESULTS, THE AUTHORS CONFIRMED A HIGH RATE OF WOUND INFECTION IN MESH REPAIR OF INCARCERATED INCISIONAL HERNIA WITH ASSOCIATED BOWEL OBSTRUCTION. THE INFECTION RATES ARE EVEN HIGHER IN PATIENTS UNDERGOING SIMULTANEOUS BOWEL SURGERY. HOWEVER, MESH EXPLANTATION IS RARELY NEEDED EVEN AFTER WOUND INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702649 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death| R