BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 12316760 · Received August 12, 2021

    Report

    Report Number
    2210968-2021-07316
    Event Type
    Injury
    Date Received
    August 12, 2021
    Date of Event
    January 1, 2020
    Report Date
    August 3, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 CLARIFY 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. COMPONENT CODE: (B)(4): DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2021-07295, 2210968-2021-07296, 2210968-2021-07297, 2210968-2021-07298, 2210968-2021-07299, 2210968-2021-07300, 2210968-2021-07301, 2210968-2021-07303, 2210968-2021-07304, 2210968-2021-07305, 2210968-2021-07306 ,2210968-2021-07307, 2210968-2021-07308, 2210968-2021-07309, 2210968-2021-07310, 2210968-2021-07311, 2210968-2021-07312, 2210968-2021-07313, 2210968-2021-07314, 2210968-2021-07315, 2210968-2021-07317, 2210968-2021-07318, 2210968-2021-07319, 2210968-2021-07320, 2210968-2021-07321, 2210968-2021-07322. CITATION: SAGEPUB.COM/JOURNALS-PERMISSIONS DOI: 10.1177/2192568219868200 JOURNALS.SAGEPUB.COM/HOME/GSJ PLEASE SEE ARTICLE ATTACHED.

    Description of Event or Problem · 1

    TITLE: REDUCING SURGICAL SITE INFECTION IN PEDIATRIC SCOLIOSIS SURGERY: A MULTIDISCIPLINARY IMPROVEMENT PROGRAM AND PROSPECTIVE 4-YEAR AUDIT. THE OBJECTIVES OF THIS STUDY IS TO EVALUATE A MULTIDISCIPLINARY LED, STRUCTURED PROTOCOL FOR REDUCING SURGICAL SITE INFECTIONS (SSIS) IN PEDIATRIC SCOLIOSIS SURGERY. IT IS A SINGLE-CENTER PROSPECTIVE COHORT STUDY. CONSULTANT SURGEONS OPERATED WITH THE ASSISTANCE OF A SENIOR SPINAL FELLOW, OR MORE RARELY WITH A SECOND CONSULTANT. LENGTH OF SURGERY WAS NOT DIRECTLY AUDITED, BUT THE NUMBER OF OPERATED LEVELS WAS USED AS A SURROGATE MARKER FOR DURATION. WOUND CLOSURE WAS PERFORMED WITH VICRYL SUTURES(ETHICON) TO THE SUBCUTANEOUS TISSUES. REGARDING SKIN CLOSURE, FOR ADOLESCENT IDIOPATHIC SCOLIOSIS CASES SUBCUTANEOUS 3.0 MONOCRYL SUTURES(ETHICON) WITH SKIN GLUE. FOR NEUROMUSCULAR CASES 2.0 NYLON SUTURES(ETHICON) INTERRUPTED SUTURES WERE APPLIED, ALSO WITH GLUE. INCLUDING THE USE OF THE FIBRIN-BASED SURGIFLO (ETHICON BIOSURGERY, LIMERICK, IRELAND) AT THE SCREW INSERTION POINTS AND AD HOC THROUGHOUT THE OPERATION WHEN BLEEDING IS ENCOUNTERED. REPORTED COMPLICATIONS INCLUDED 14 YEARS OLD FEMALE- SURGICAL SITE INFECTION 8 YEARS OLD FEMALE- SURGICAL SITE INFECTION, 2 YEARS OLD FEMALE - SURGICAL SITE INFECTION, 7 YEARS OLD FEMALE -SURGICAL SITE INFECTION, 14 YEARS OLD FEMALE - SURGICAL SITE INFECTION, 16 YEARS OLD FEMALE - SURGICAL SITE INFECTION, 12 YEARS OLD FEMALE - SURGICAL SITE INFECTION, 9 YEARS OLD FEMALE - SURGICAL SITE INFECTION 11 YEARS OLD FEMALE - SURGICAL SITE INFECTION. IN CONCLUSION A MULTIDISCIPLINARY APPROACH WITH STANDARDIZED MEASURES SIGNIFICANTLY REDUCED SSIS IN THE UNIT¿S PEDIATRIC SCOLIOSIS SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1212665 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention