BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT

    MDR report key: 18768675 · Received February 23, 2024

    Report

    Report Number
    2210968-2024-01792
    Event Type
    Injury
    Date Received
    February 23, 2024
    Date of Event
    June 28, 2023
    Report Date
    February 23, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    OMD
    PMA / PMN Number
    K082289
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION: H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NOT RECEIVED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED (VICRYL SUTURE AND DERMABOND PRINEO) CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS: T JUNCTION DEHISCENCE, POSTOPERATIVE INFECTION, HEMATOMA, SUPERFICIAL WOUND HEALING PROBLEM, SEROMA, SKIN FLAP ISCHEMIA, HYPERTROPHIC SCAR, FAT NECROSIS, PARTIAL NIPPLE ISCHEMIA, DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS (VICRYL SUTURE AND DERMABOND PRINEO) USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WHICH SPECIFIC ETHICON PRODUCTS (VICRYL SUTURE AND DERMABOND PRINEO) HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? PATIENT DEMOGRAPHICS? THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. NO PRODUCT AVAILABLE FOR RETURN. NOTE: EVENTS REPORTED VIA: MW# 2210968-2024-01792, MW# 2210968-2024-01793. CITATION: AESTH PLAST SURG; HTTPS://DOI.ORG/10.1007/S00266-023-03442-8. 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, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: THE INFERO-CENTRAL MOUND REDUCTION MAMMOPLASTY: A SINGLE SURGEON, 20-YEAR EXPERIENCE THIS STUDY DESCRIBES THE SENIOR AUTHOR¿S UNIQUE REDUCTION MAMMOPLASTY TECHNIQUE, EMPLOYING THE INFERO-CENTRAL PEDICLE THROUGHOUT THE LAST 2 DECADES. BETWEEN 2000 AND 2020, 360 WOMEN WHO UNDERWENT INFERO-CENTRAL REDUCTION MAMMOPLASTY WERE INCLUDED IN THE STUDY. THE PATIENTS¿ MEAN AGE WAS 39 YEARS (RANGE, 15-78) AND THE MEAN BMI WAS 26.1 KG/M2 (RANGE, 17.5¿39.1). DURING THE PROCEDURE, THE 1/0 OR 2/0 VICRYL SUTURES (ETHICON) WERE USED TO FURTHER STABILIZE THE BREAST MOUND ON THE DESIRED LOCATION OVER THE CHEST WALL. ADDITIONAL SUPERIOR OF MEDIAL SUTURES WERE USED AS NEEDED TO FURTHER FIXATE THE NEW MOUND. CLOSURE IN LAYERS OVER A CLOSED SUCTION DRAIN WAS PERFORMED. UPON COMPLETION OF SUTURING, WOUNDS WERE CLOSED WITH EITHER A COMPETITOR STERISTRIPS (MANUFACTURER: 3M) OR PRINEO (DERMABOND) ADHESIVE MESH (ETHICON) AND WRAPPED IN A MEDICAL BRA. PATIENTS WERE USUALLY DISCHARGED HOME THE DAY AFTER SURGERY. DRAINS WERE GENERALLY REMOVED BEFORE DISCHARGE, EXCEPT FOR CASES WITH HIGH OUTPUT (OVER 30 ML OVER 24 HOURS). REPORTED COMPLICATIONS INCLUDED T JUNCTION DEHISCENCE (N=26), POSTOPERATIVE INFECTION (N=16), HEMATOMA (N=12), SUPERFICIAL WOUND HEALING PROBLEM (N=10), SEROMA (N=5), SKIN FLAP ISCHEMIA (N=11), HYPERTROPHIC SCAR (N=10), FAT NECROSIS (N=9), AND PARTIAL NIPPLE ISCHEMIA (N=2). IN CONCLUSION, INFERO-CENTRAL MOUND TECHNIQUE CAN BE APPLIED TO BREAST REDUCTIONS OF NEARLY ALL SIZES, ALLOWING FOR CONSISTENTLY SATISFACTORY AESTHETIC OUTCOMES FOR MOST PATIENTS. DUE TO ROBUST VASCULARITY OF THE PEDICLE, COMPLICATION RATES ARE KEPT AT A MINIMUM. INFERO-CENTRAL MOUND TECHNIQUE IS AN ESSENTIAL TOOL IN THE PLASTIC SURGEON¿S ARMAMENTARIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212407 PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT SURGICAL SEALANT OMD ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention