BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE BLUE 1.50M 45CM W/NDL

    MDR report key: 14574479 · Received June 2, 2022

    Report

    Report Number
    2210968-2022-04235
    Event Type
    Injury
    Date Received
    June 2, 2022
    Date of Event
    July 1, 2021
    Report Date
    June 14, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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? 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. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: CHINESE NURSING RESEARCH JULY, 2021 VOL. 35 NO. 14:2600-2603. DOI: 10. 12102/J. ISSN. 1009-6493. 2021. 14. 032.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 6/14/2022. 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. THE FOLLOWING INFORMATION WAS REQUESTED BUT UNAVAILABLE: DOES THE SURGEON BELIEVE THAT ANY OF THE 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 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?

    Description of Event or Problem · 0

    TITLE: COMPARISON OF APPLICATION EFFECT OF TWO REWIRABLE INCISION SUTURE IN ABDOMINAL TRANSVERSE INCISION OF CESAREAN SECTION IN PARTURIENTS WITH PREMATURE RUPTURE OF MEMBRANES. THE AIM OF THIS STUDY WAS TO COMPARE 4-0 ANGULAR NEEDLE POLYPROPYLENE NONABSORBABLE SUTURE (PROLENE) CONTINUOUS INTRADERMAL SUTURE AND DISPOSABLE SKIN STAPLER INTERRUPTED SUTURE IN THE ABDOMEN OF PARTURIENTS UNDERGOING CESAREAN SECTION APPLICATION EFFECT OF WALL TRANSVERSE INCISION. FROM OCTOBER 2019 TO JUNE 2020, 102 PARTURIENTS WITH FETAL MEMBRANES WHO UNDERWENT EMERGENCY CESAREAN SECTION WITH TRANSVERSE ABDOMINAL INCISION IN THE OPERATING ROOM OF OUR HOSPITAL WERE SELECTED AS STUDY SUBJECTS: PARTURIENTS WERE DIVIDED INTO OBSERVATION GROUP AND CONTROL GROUP ACCORDING TO SUTURE METHOD, 51 CASES FOR EACH GROUP. IN THE OBSERVATION GROUP (N=51; MEAN AGE OF 28.57 ± 4.64 YEARS), 4-0 ANGULAR NEEDLE POLYPROPYLENE NONABSORBABLE SUTURE (PROLENE WITH MODEL W8683) WERE USED FOR CONTINUOUS INTRADERMAL SUTURE OF THE SUPERFICIAL SKIN OF THE INCISION, AND BOTH ENDS WERE FIXED WITH LOCK CATCH. IN THE CONTROL GROUP (N=51; MEAN AGE OF 28.18 ± 5.12 YEARS), INTERRUPTED SUTURE WAS PERFORMED USING A DISPOSABLE SKIN STAPLER FROM COMPETITOR. REPORTED COMPLICATIONS INCLUDE INCISION EXUDATE (N=1) ON POSTOPERATIVE DAY 11. IN CONCLUSION, COMPARED WITH INTERRUPTED SUTURE USING DISPOSABLE SKIN STAPLER, 4-0 ANGLE NEEDLE POLYPROPYLENE NON-ABSORBABLE SUTURE (PROLENE) HAD SLIGHTLY LONGER CONTINUOUS INTRADERMAL SUTURE TIME, BUT LOWER SUTURE COST, LESS POSTOPERATIVE PAIN, LESS SCAR AND BETTER INCISION COSMESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153884 PROLENE BLUE 1.50M 45CM W/NDL SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention