BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT

    MDR report key: 18768522 · Received February 23, 2024

    Report

    Report Number
    2210968-2024-01782
    Event Type
    Injury
    Date Received
    February 23, 2024
    Date of Event
    July 20, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    OMD
    PMA / PMN Number
    K082289
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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. AN ATTEMPT HAS BEEN 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. CITATION: JOURNAL OF SURGICAL RESEARCH. HTTPS://DOI.ORG/10.1016/J.JSS.2023.07.035. RELATED EVENTS CAPTURED VIA 2210968-2024-01783.

    Description of Event or Problem · 0

    TITLE : OPTIMIZING TISSUE OXYGENATION IN REDUCTION MAMMOPLASTY: THE ROLE OF CONTINUOUS DIFFUSION OF OXYGEN: A FEASIBILITY PILOT RANDOMIZED CONTROLLED TRIAL. THE AIM OF THIS STUDY IS TO EXAMINE THE FEASIBILITY OF HOME-BASED CDO (CONTINUOUS DIFFUSION OF OXYGEN) THERAPY IN PATIENTS UNDERGOING BRM, WITH THE HYPOTHESIS THAT CDO IS SAFE AND ACCEPTABLE WITHIN THIS POPULATION. A 4-WK FEASIBILITY-PILOT RANDOMIZED CONTROLLED TRIAL OF WOMEN UNDERGOING BRM BETWEEN JULY 2021 AND APRIL 2023 WAS CONDUCTED. CONSEQUENTLY, THE STUDY INCLUDED A TOTAL OF 16 PARTICIPANTS (AGE ¼ 33 8 Y, BODY MASS INDEX ¼ 34.34 - 5.85 KG/M2), CORRESPONDING TO N ¼ 32 BREASTS GROUP WAS DIVIDED INTO 2. (A.) DCDO ¿ DIRECT CONTINUOUS DIFFUSION OF OXYGEN AND (B.) SCDO ¿ SILICONE CONTINUOUS DIFFUSION OF OXYGEN. FOR DCDO GROUP, ALL WOUNDS WERE CLOSED IN A WISE PATTERN EITHER WITH INFERO OR SUPEROMEDIAL PEDICLE INCISION PATTERN. THE NIPPLE AREOLAS WERE INSET WITH 3-0 MONOCRYL FOR DEEP DERMAL AND A RUNNING 4-0 MONOCRYL SUBCUTICULAR SUTURE. THE REST OF THE BREAST SKIN WAS INSET WITH 3-0 MONOCRYL FOR DEEP DERMAL AND A RUNNING 3-0 MONOCRYL SUBCUTICULAR SUTURE. THE DRESSING WAS PLACED DIRECTLY TO THE CLOSED WOUND IN A 5.1 CM- 5.1 CM SKIN AREA PROTECTED BY A 10 CM- 12 CM TEGADERM TM FILM (3M HEALTHCARE- COMPETITOR). ALL OTHER AREAS OF THE PEDICLE (I.E., MEDIAL, LATERAL, NIPPLE AREA) WERE DRESSED IN A TOPICAL SKIN ADHESIVE SYSTEM DERMABOND PRINEO OR EXOFIN PRECISION PEN (COMPETITOR). IN SCDO GROUP, THIS GROUP INCLUDED THE PREVIOUSLY MENTIONED TOPICAL SKIN ADHESIVE SYSTEM IN BOTH THE T JUNCTION AND ALL PEDICLES FOLLOWED BY A 5.1 CM- 5.1 CM DRESSING (OXYSPUR, EO2 COMPETITOR) PROTECTED BY A 10 CM-12 CM SILICON SHEET (SILAGEN ¿ COMPETITOR). REPORTED COMPLICATION: WOUND DEHISCENCE (N-1). CONCLUSION TO OUR KNOWLEDGE, THIS IS THE FIRST STUDY DEMONSTRATING THE FEASIBILITY, SAFETY, AND ACCEPTABILITY OF SELF-APPLIED CDO THERAPY TO BREAST WOUNDS IN PATIENTS UNDERGOING BRM. THIS TREATMENT WAS ACCEPTABLE AND MAY LEAD TO FUTURE PROTOCOLS INCLUDING LONGER THERAPY PERIODS AND FOLLOW-UP EVALUATIONS. EXPLORATORY FINDINGS SUGGEST THAT WOUND ENVIRONMENT SUPPORTED BY THE PROPER UTILIZATION OF EXTERNAL AGENTS MAY POTENTIALLY ENHANCE THE BREAST TISSUE OXYGENATION EFFECT OF APPLIED CDO TO THE T-JUNCTION SITE. AS THERE WAS A LACK OF SIGNIFICANT DIFFERENCE REGARDING WOUND DEHISCENCE BETWEEN BREAST GROUPS, IT IS UNCLEAR WHETHER CDO PREVENTS THIS COMPLICATION. HOWEVER, RESULTS COULD BE CONFIRMED IN LARGER COHORTS AS THERE WAS A LARGE EFFECT SIZE SEEN FOR THE OXYGEN EXPLORATORY OUTCOME COMPARISON. IN FUTURE TRIALS, OTHER KNOWN CONFOUNDERS FOR BREAST SURGERY (I.E., SURGICAL-IPSILATERAL DOMINANT ARM MOTION) SHOULD BE INVESTIGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115519 PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT SURGICAL SEALANT OMD ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other