BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT

    MDR report key: 13054494 · Received December 21, 2021

    Report

    Report Number
    2210968-2021-12833
    Event Type
    Injury
    Date Received
    December 21, 2021
    Date of Event
    August 27, 2020
    Report Date
    December 21, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    OMD
    PMA / PMN Number
    K082289
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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 (PRINEO) CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS (INFECTION, WOUND COMPLICATIONS AND SURGICAL SITE INFECTION) DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS ( PRINEO) 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. 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION CITE: S.S. JOHNSTON ET AL. / THE SPINE JOURNAL 21 (2021) 45-54. HTTPS://DOI.ORG/10.1016/J.SPINEE.2020.08.017.

    Description of Event or Problem · 0

    TITLE: ECONOMIC AND CLINICAL OUTCOMES OF SPINAL FUSION SURGERIES WITH SKIN CLOSURE THROUGH SKIN STAPLES PLUS WATERPROOF WOUND DRESSINGS VERSUS 2-OCTYL CYANOACRYLATE PLUS POLYMER MESH TAPE THE PURPOSE OF THIS STUDY IS TO COMPARE THE ECONOMIC AND CLINICAL OUTCOMES OF SPINAL FUSION SURGERIES USING ONE OF TWO SUTURELESS SKIN CLOSURE TECHNIQUES: SKIN STAPLES PLUS WATERPROOF WOUND DRESSINGS (SSWWD) OR 2-OCTYL CYANOACRYLATE PLUS POLYMER MESH TAPE (2OPMT). A TOTAL OF 11,991 PATIENTS MET THE STUDY CRITERIA AND UNDERWENT SPINAL FUSION SURGERY FOR A SPINE DISORDER BETWEEN OCTOBER 1, 2015 AND MARCH 31, 2019. 2-OCTYL CYANOACRYLATE [DERMABOND ; ETHICON INC, NJ, USA]) WAS USED . REPORTED COMPLICATIONS INCLUDED LOWER RATE OF INFECTIONS, WOUND COMPLICATIONS AND SURGICAL SITE INFECTION. IN CONCLUSION IN THIS RETROSPECTIVE OBSERVATIONAL STUDY OF PATIENTS UNDERGOING ELECTIVE INPATIENT SPINAL FUSION SURGERY, THE USE OF 2OPMT FOR SKIN CLOSURE WAS ASSOCIATED WITH SIGNIFICANTLY LOWER ORT, LOS, NON-HOME DISCHARGE, AND 90-DAY RATES OF INFECTIONS/WOUND COMPLICATIONS AS COMPARED WITH SSWWD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1950190 PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT SURGICAL SEALANT OMD ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention