BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATAFIX SPIRAL PDS PLUS UNKNOWN

    MDR report key: 18876346 · Received March 11, 2024

    Report

    Report Number
    2210968-2024-02813
    Event Type
    Injury
    Date Received
    March 11, 2024
    Date of Event
    January 1, 2022
    Report Date
    March 18, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THE FOLLOWING INFORMATION HAS BEEN REQUESTED AND RECEIVED. IF THE FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. NO FURTHER INFORMATION WILL BE PROVIDED BECAUSE WE CAN¿T GET ANY ADDITIONAL INFORMATION FROM THE AUTHOR. 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 BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. 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, 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. 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, 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. TRADE NAME - IRGACARE®. ACTIVE INGREDIENT(S) ¿ TRICLOSAN. DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL. STRENGTH ¿ 2360 G/M. 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 2210968-2024-02812. CITATION: ASIAN CARDIOVASCULAR & THORACIC ANNALS 2022;30(7):807¿812. HTTPS://DOI.ORG/10.1177/02184923221106770.

    Description of Event or Problem · 0

    TITLE: KNOTLESS SUTURE AND HYDROCOLLOID METHOD IMPROVES CHEST DRAIN WOUND COMPLICATION. THIS STUDY AIMED TO EVALUATE A CHEST DRAIN WOUND CLOSURE METHOD USING A KNOTLESS SUTURE AND COMPARE IT WITH CLOSURE BY LIGATION. BETWEEN OCTOBER 2020 TO APRIL 2021, A TOTAL OF 117 PATIENTS (74 MALE AND 43 FEMALE; MEAN AGE WAS 61.1 YEARS) UNDERWENT CLOSURE WITH HORIZONTAL CONTINUOUS INTRADERMAL SUTURES USING 3-0 STRATAFIX¿ SPIRAL PDS¿ PLUS KNOTLESS TISSUE CONTROL DEVICE (STRATAFIX) (ETHICON US, LLC; CINCINNATI, OH, USA) AT THE CHEST DRAIN INSERTION SITE (KNOTLESS GROUP). THE CLOSURE TECHNIQUE ALSO INVOLVES SEWING THE INTERCOSTAL MUSCLES AT THE DRAIN INSERTION AREA WITH A 3-0 VICRYL® (ETHICON) SUTURE, FOLLOWED BY A HORIZONTAL CONTINUOUS INTRADERMAL SUTURE STRATAFIX. HYDROCOLLOID DRESSING IS APPLIED TO THE DRAIN WOUND AFTER CHEST DRAIN REMOVAL IN A KNOTLESS SUTURE. THESE PATIENTS WERE COMPARED WITH THOSE OF MATTRESS SUTURE USING 2-0 NYLON IN 115 PATIENTS (84 MALE AND 31 FEMALE; MEAN AGE WAS 57.4 YEARS) WHO UNDERWENT THORACIC SURGERY BETWEEN OCTOBER 2018 AND APRIL 2019. REPORTED COMPLICATIONS INCLUDE (N=6) REQUIRING ADDITIONAL TREATMENT (PLEURAL EFFUSION FROM AN INCOMPLETELY CLOSED WOUND AFTER CHEST DRAIN REMOVAL, REQUIRING SKIN STAPLING OR COMPRESSION TREATMENT WITH GAUZE) AND (N=1) DELAYED DRAIN WOUND HEALING. IN CONCLUSION, THE RESULTS OF KNOTLESS CLOSURE WERE BETTER THAN THOSE OF CONVENTIONAL MATTRESS SUTURE REGARDING WOUND COMPLICATIONS. MOREOVER, KNOTLESS SUTURING REQUIRES NO SUTURE REMOVAL, INDICATING ITS USEFULNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2010525 STRATAFIX SPIRAL PDS PLUS UNKNOWN SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention