BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 19029296 · Received April 2, 2024

    Report

    Report Number
    2210968-2024-03767
    Event Type
    Injury
    Date Received
    April 2, 2024
    Date of Event
    February 13, 2023
    Report Date
    April 2, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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 2210968-2024-03766 CITATION: HTTPS://DOI.ORG/10.1016/J.BJPS.2023.02.018.

    Description of Event or Problem · 0

    TITLE: COMPARISON OF SURGICAL AND PATIENTREPORTED OUTCOMES BETWEEN 85 PROFUNDA ARTERY PERFORATOR FLAPS AND 122 DEEP INFERIOR EPIGASTRIC PERFORATOR FLAPS AS FIRSTCHOICE TREATMENT FOR BREAST RECONSTRUCTION THIS STUDY DESCRIBES PERIOPERATIVE MEASURE, CLINICAL OUTCOMES, AND PATIENT-REPORTED OUTCOME MEASURES IN COMPARISON TO THE GOLD STANDARD, THE DEEP INFERIOR EPIGASTRIC PERFORATOR (DIEP) FLAP. IN THIS STUDY, IT WAS ANALYZED THAT ALL PROFUNDA ARTERY PERFORATOR (PAP) FLAPS AND DEEP INFERIOR EPIGASTRIC PERFORATOR (DIEP) FLAPS PERFORMED IN A SINGLE CENTER BETWEEN MARCH 2018 AND DECEMBER 2020. A TOTAL OF 85 PAP FLAPS AND 122 DIEP FLAPS WERE PERFORMED WITHIN 34 MONTHS. ALL PATIENTS WERE FEMALE WITH A MEAN AGE RANGES 17-77 YEARS IN THE PAP GROUP AND RANGES 23-71 YEARS IN THE DIEP GROUP. AN IMPLANT SHAPE WAS CREATED BY ATTACHING THE VENTRAL AND DORSAL FLAP TIPS AND CLOSURE OF THE DONOR-SITE WITH 2-0 VICRYL SUTURE (ETHICON). INTRACUTANEOUS SUTURES WERE DONE WITH 3-0 MONOCRYL SUTURE (ETHICON) AND WERE PLACED TO REDUCE WOUND TENSION. REPORTED COMPLICATION ARE TOTAL FLAP LOSS, PARTIAL FLAP LOSS, FAT NECROSIS, ANASTOMOSIS REVISION, INFECTION DONOR-SITE (DS), WOUND DEHISCENCE DONOR-SITE (DS), SEROMA DONOR-SITE (DS). IN CONCLUSION, WHILE THE PAP FLAP DEMONSTRATED FAVORABLE PERIOPERATIVE MEASURES, OUTCOME MEASURES WERE BETTER WITH THE DIEP FLAP. THE PAP FLAP IS FAIRLY NEW AND DEMONSTRATES HIGH POTENTIAL WHILE STILL SHOWING A NEED FOR REFINEMENT COMPARED TO THE DIEP FLAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1405763 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention