BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 18833668 · Received March 4, 2024

    Report

    Report Number
    2210968-2024-02342
    Event Type
    Injury
    Date Received
    March 4, 2024
    Date of Event
    January 1, 2023
    Report Date
    March 4, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2024-02342 AND 2210968-2024-02343. CITATION: HTTPS://DOI.ORG/10.53555/JPTCP.V30I18.3350.

    Description of Event or Problem · 0

    TITLE: COMPARISON OF INCIDENCE OF POSTOPERATIVE STERNOTOMY SURGICAL SITE INFECTIONS AND IMPACT OF SUTURE TYPE (ABSORBABLE OR NON-ABSORBABLE) ON ITS FREQUENCY. THE AIM OF THIS ANALYSIS WAS TO EVALUATE THE DIFFERENCE IN INCIDENCE OF SURGICAL SITE INFECTION WITH USE OF PROLENE (SYNTHETIC MONOFILAMENT NON ABSORBABLE POLYPROPYLENE) SUTURES AND 4-0 VICRYL (SYNTHETIC MONOFILAMENT ABSORBABLE POLYGLACTIN) SUTURES. BETWEEN 1ST APRIL 2023 TO 30TH SEPTEMBER 2023, THEY PROSPECTIVELY INDUCTED PATIENTS IN THEIR STUDY IN WHICH ABSORBABLE SUTURE WAS USED THROUGH CONSECUTIVE SAMPLING, AND THERE WERE 33 PATIENTS IN WHICH THIS SUTURE WAS USED DURING THE STUDY PERIOD. SAME NUMBER (N = 33) OF MATCHING CASES IN WHICH NON ABSORBABLE SUTURE WAS USED WERE INDUCTED, A TOTAL OF 66 PATIENTS (GROUP 1; 22 MALES, 11 FEMALES WITH MEAN AGE OF 52.92±7.06 YEARS AND GROUP 2; 20 MALES, 13 FEMALES WITH MEAN AGE OF 49.45±5.74 YEARS). THE PARTICIPANTS WERE SELECTED FROM THE PATIENTS WHO UNDERWENT AN ELECTIVE CABG SURGERY OR VALVE REPAIR WITH CABG. THE SURGERY WAS DONE ACCORDING TO STANDARD PROTOCOLS FOR CABG AND THE STERNUM WAS CLOSED WITH SS WIRES. THE SOFT TISSUE WAS CLOSED WITH VICRYL IN 33 CASES AND WITH PROLENE IN 33 MATCHING CASES (PATIENTS WITH SIMILAR CLINICAL CHARACTERISTICS). THE POSTOPERATIVE EVALUATION WAS DONE ON DAY 3 AND DAY 30 IN POSTOPERATIVE FOLLOW-UP. THE FOLLOWING EVENTS CANNOT BE RULED OUT AS COMPLAINTS: PATIENT INFORMATION: GROUP 1, PROLENE (SYNTHETIC MONOFILAMENT NON ABSORBABLE POLYPROPYLENE). (N=12) SUPERFICIAL WOUND INFECTIONS. (N=2) BLEEDING AT SUTURE SITE. (N=7) WOUND INFECTIONS WITH DISCHARGE (CULTURE POSITIVE) AT FOLLOW-UP. (N=8) ASEPSIS SCORE >40. TREATMENT: NO TREATMENT MENTIONED IN THIS GROUP. GROUP 2, 4-0 VICRYL (SYNTHETIC MONOFILAMENT ABSORBABLE POLYGLACTIN) SUTURES. (N=9) SUPERFICIAL WOUND INFECTIONS. (N=1) BLEEDING AT SUTURE SITE. (N=4) WOUND INFECTIONS WITH DISCHARGE (CULTURE POSITIVE) AT FOLLOW-UP. (N=4) ASEPSIS SCORE >40. TREATMENT: NO TREATMENT MENTIONED IN THIS GROUP. IN CONCLUSION, THE NUMBER OF INFECTIONS WAS FEWER IN GROUP 2 INDICATING THAT USE OF ABSORBABLE SUTURES MAY REDUCE THE CHANCES OF SURGICAL SITE INFECTIONS. THE RESULTS EMPLOY THAT, ABSORBABLE VICRYL SUTURES CAN BE USED IN WOUND CLOSURE IN STERNOTOMY PROCEDURES WITH SAFETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1519507 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other