BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 19115659 · Received April 16, 2024

    Report

    Report Number
    2210968-2024-04353
    Event Type
    Injury
    Date Received
    April 16, 2024
    Date of Event
    January 1, 2023
    Report Date
    April 26, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 2210968-2024-04353 AND 2210968-2024-04354. CITATION: ANNALS OF OTOLOGY, RHINOLOGY & LARYNGOLOGY 2023, VOL. 132(12):1528¿1534. HTTPS://DOI.ORG/10.1177/00034894231170582.

    Description of Event or Problem · 0

    TITLE: CLOSURE OF TRACHEOCUTANEOUS FISTULAE IN PATIENTS WITH CHALLENGED WOUND HEALING. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO DESCRIBE AND EVALUATE THE SURGICAL OUTCOMES OF MULTILAYERED CLOSURE OF PERSISTENT TRACHEOCUTANEOUS FISTULAE (TCF) IN PATIENTS WITH CHALLENGED WOUND HEALING. BETWEEN OCTOBER 2011 AND DECEMBER 2021, A TOTAL OF 35 PATIENTS (16 MALES AND 19 FEMALES) WHO UNDERWENT TCF REPAIR WERE INCLUDED IN THE STUDY. THE MEAN AGE WAS 62.9 (RANGE 31-93 YEARS), AND THE MEAN BMI WAS 28.47 (RANGE 16.14-56.33). AMONG THESE, 26 PATIENTS MET CRITERIA FOR CHALLENGED WOUND HEALING AT THE TIME OF THE TCF REPAIR. DURING THE SURGERY, THE FISTULA TRACT IS CLOSED USING A 2-LAYER RUNNING HORIZONTAL MATTRESS 3-0 POLYGLACTIN 910 SUTURE (ETHICON, RARITAN, NJ) JUST BENEATH THE HEMOSTAT TO ALLOW FOR AN AIRTIGHT REPAIR. ANY EXCESS SKIN SUPERFICIAL TO THE CLOSURE IS THEN TRIMMED SHARPLY (FIGURE 3). THE STRAP MUSCLES ARE THEN FREED FROM THE LATERAL TRACHEA ON EACH SIDE, MOBILIZED MEDIALLY AND SUTURED TOGETHER IN THE MIDLINE USING INTERRUPTED 3-0 POLYGLACTIN 910 SUTURES (ETHICON, RARITAN, NJ) OVER A STERILE RUBBER BAND DRAIN WHICH IS BROUGHT OUT OF THE WOUND INFERIORLY. THE SKIN IS CLOSED IN 2 LAYERS USING INTERRUPTED 3-0 POLYGLACTIN 910 (ETHICON, RARITAN, NJ), FOLLOWED BY A RUNNING SUBCUTICULAR 4-0 POLYGLECAPRONE 25 SUTURE (ETHICON, RARITAN, NJ). REPORTED COMPLICATIONS INCLUDE POST-OPERATIVE WOUND INFECTION THAT PRESENTED AS WOUND DRAINAGE AND INCISIONAL SORENESS (N=1), WHICH WAS SUCCESSFULLY TREATED WITH ORAL ANTIBIOTICS. IN CONCLUSION, MULTILAYERED CLOSURE OF PERSISTENT TRACHEOCUTANEOUS FISTULAE IS A SIMPLE TECHNIQUE WHICH IS SAFE AND EFFECTIVE EVEN IN PATIENTS WITH CHALLENGED WOUND HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691781 POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention