BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 16619808 · Received March 27, 2023

    Report

    Report Number
    2210968-2023-02068
    Event Type
    Injury
    Date Received
    March 27, 2023
    Date of Event
    August 1, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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 INC, 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. 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 ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: NINGXIA MEDICAL JOURNAL (AUGUST 2018); 40(8):711-713. DOI: 10.13621/J. 1001 -5949.2018.08.0711.

    Description of Event or Problem · 0

    TITLE: CLINICAL ANALYSIS OF SEVERE PELVIC ORGAN PROLAPSE IN THREE SURGICAL TREATMENTS. THE AIM OF THIS STUDY WAS TO EXPLORE THE THREE KINDS OF SURGICAL TREATMENT OF PELVIC ORGAN PROLAPSE, AND TO COMPARE THE ADVANTAGES AND DISADVANTAGES OF THE THREE OPERATIONS TO PROVIDE A THEORETICAL BASIS FOR CLINICAL PRACTICE. BETWEEN JUNE 2015 TO JUNE 2017, A TOTAL OF 49 PATIENTS DIAGNOSED PELVIC ORGAN PROLAPSE WERE INCLUDED IN THE STUDY. AMONG THEM, 20 PATIENTS UNDERWENT ROUTINE COLPOSCOPY HYSTERESIS + VAGINAL ANTERIOR-POSTERIOR WALL REPAIR (GROUP A) USING POLYPROPYLENE PATCHES PRODUCED BY JOHNSON & JOHNSON USA. 20 PATIENTS UNDERWENT LAPAROSCOPIC LONGITUDE LIGAMENT FIXATION OF THE UTERUS (GROUP B) USING "Y" PATCHES FROM JOHNSON & JOHNSON. 9 PATIENTS UNDERWENT ROUTINE LAPAROSCOPIC COLPOSCOPY FIXATION + VAGINAL WALL REPAIR (GROUP C). REPORTED COMPLICATIONS INCLUDE URINARY RETENTION (N=1) AND MESH EXPOSURE (N=1) IN GROUP A; AND PELVIC PAIN (N=1) IN GROUP B. IN CONCLUSION, THREE OPERATION METHODS ALL ARE SAFE AND EFFECTIVE. THEY ALL HAVE MERITS AND DEMERITS. IN CLINICAL THERAPY, WE SHOULD CONSIDER AND REALIZE INDIVIDUAL TREATMENT BASE ON THE PATIENTS WISHES, AGE, DEGREE OF ORGAN PROLAPSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1808906 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other