BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS LL PLUS ANTIBACTERIAL SUTURE UNKNOWN PRODUCT

    MDR report key: 20543395 · Received October 28, 2024

    Report

    Report Number
    2210968-2024-11136
    Event Type
    Injury
    Date Received
    October 28, 2024
    Date of Event
    April 12, 2024
    Report Date
    October 31, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    K061037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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. 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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (B)(4) IS NOT AVAILABLE. CITATION: HERNIA HTTPS://DOI.ORG/10.1007/S10029-024-03012-0.

    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. THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DRRA) FOR PATIENTS UNDERGOING HERNIA REPALR PROCEDURES. THIS REPORT IS RELATED TO A CLINICAL EVALUATION REPORT; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. ADDITIONAL INFORMATION RECEIVED: READMISSION (N=7) ADDITIONAL INFORMATION H6 HEALTH EFFECT - IMPACT CODE.

    Description of Event or Problem · 0

    TITLE: CLINICAL OUTCOMES OF TRICLOSAN-COATED BARBED SUTURE IN OPEN HERNIA REPAIR: A RETROSPECTIVE COHORT STUDY. THE PURPOSE OF THE STUDY IS TO ASSESS CLINICAL OUTCOMES OF PATIENTS UNDERGOING OPEN HERNIA REPAIR USING STRATAFIX¿ SYMMETRIC, A BARBED TRICLOSAN-COATED SUTURE (TCS; ETHICON), VERSUS CONVENTIONAL POLYDIOXANONE SUTURE (PDS) FOR ABDOMINAL WALL CLOSURE. FROM JANUARY 2013 TO AUGUST 2020, PATIENTS UNDERGOING OPEN HERNIA REPAIRS WERE INCLUDED IN THE STUDY. CONVENTIONAL ETHICON PDS SUTURE (NON-PLUS PRODUCT USED INITIALLY IN THE STUDY PERIOD, WITH A SWITCH TO TRICLOSAN-COATED PLUS PRODUCT LATER) WAS USED FROM JANUARY 1, 2013 TO JULY 5, 2016 AND WAS REPLACED BY BARBED TCS (STRATAFIX¿ SYMMETRIC SUTURE; ETHICON) FROM JULY 6, 2017 TO AUGUST 31, 2020. OF 821 HERNIA REPAIRS, 446 USED BARBED TCS AND 375 USED CONVENTIONAL PDS. DURING THE PROCEDURE, THE POSTERIOR LAYER WAS CLOSED USING A RESORBABLE VICRYL 2/0 SUTURE (ETHICON), AND A COMPETITOR LARGE PORE MONOFILAMENT POLYPROPYLENE OR POLYVINYLIDENE FLUORIDE MESH (MANUFACTURER: UNKNOWN) WAS PLACED TO REINFORCE THE REPAIR. ONCE THE MESH WAS IN PLACE WITH AN OVERLAP OF AT LEAST 5 CM TO ALL SIDES, IT WAS FIXED TO BONY EDGES USING A COMPETITOR (TI-CRON 1) MULTIFILAMENT SUTURE OR TO THE POSTERIOR LAYER USING SEPARATE RESORBABLE SUTURES (VICRYL 3/0, ETHICON) FOR EACH QUADRANT. THE ANTERIOR FASCIA WAS SUTURED TOGETHER USING PDS 1 OR A BARBED TRICLOSAN-COATED SUTURE 1 (ETHICON) OR 0 (STRATAFIX SYMMETRIC PDS PLUS 1 OR 0, ETHICON), AND THE MIDLINE WAS COMPLETELY RECONSTRUCTED USING MESH AUGMENTATION. IN CASE A BILATERAL ANTERIOR COMPONENT SEPARATION TECHNIQUE WAS NEEDED A RUNNING PDS 2/0 (ETHICON) WAS USED ALL AROUND TO FIX THE MESH TO THE PERITONEUM. REPORTED COMPLICATIONS INCLUDED SURGICAL SITE INFECTION AT 60 DAYS FOLLOW-UP (N=64) AND AT 90 DAYS FOLLOW-UP( (N=65), DEEP SURGICAL SITE INFECTION AT 60 DAYS FOLLOW-UP (N= 17) AND AT 90 DAYS FOLLOW-UP (N=17), WOUND DEHISCENCE (N=?), AND UNSPECIFIED PERIOPERATIVE COMPLICATIONS NEEDING REOPERATION. (N=?). IN CONCLUSION, THIS STUDY SHOWED THAT PATIENTS WHO UNDERWENT OPEN HERNIA REPAIR APPEARED TO RECOVER EQUALLY WELL REGARDLESS OF THE SUTURE TYPE. IN ADDITION, THE USE OF BARBED TCS WAS ASSOCIATED WITH SIGNIFICANTLY REDUCED RISK OF PERIOPERATIVE COMPLICATIONS AND HOSPITAL LENGTH OF STAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1958262 PDS LL PLUS ANTIBACTERIAL SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention