BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN VICRYL RAPIDE SUTURE

    MDR report key: 10550727 · Received September 17, 2020

    Report

    Report Number
    2210968-2020-07067
    Event Type
    Malfunction
    Date Received
    September 17, 2020
    Report Date
    September 7, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K033746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT (B)(4). 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. ATTEMPTS ARE BEING MADE TO OBTAIN THE ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE 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 ETHICON PRODUCT INVOLVED (VICRYL RAPIDE SUTURE) CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT (VICRYL RAPIDE SUTURE) USED IN THIS PROCEDURE? PATIENT DEMOGRAPHICS. CITATION: NOT REPORTED. DOI: HTTPS://DOI.ORG/10.1016/J.BJPS.2017.11.011. ADVERSE EVENTS WERE SUBMITTED VIA 2210968-2020-07064.

    Description of Event or Problem · 1

    TITLE: SERIAL EXCISION WITH POWERSTRETCHING OF THE SKIN IN GIANT MELANOCYTIC NEVI THERAPY THIS AUTHOR¿S RESPONSE AIMED TO PRESENT A SURGICAL METHOD THAT TAKES ADVANTAGE OF THE HIGH SKIN-ELASTICITY AND THE SMALL ABSOLUTE SIZE OF GIANT CONGENITAL MELANOCYTIC NEVI (GCMNS) IN VERY YOUNG CHILDREN. BETWEEN 1998 AND 2012, 78 PATIENTS (AGE 3 TO 12 MONTHS, MEAN 12 MONTHS) WITH GCMN WHO WERE TREATED WITH POWER-STRETCHING OF THE SKIN WITH INTRACUTANEOUS HIGH TRACTION SUTURES WERE INCLUDED IN THE STUDY. IN THE PROCEDURE, ADDITIONAL INTERRUPTED OR RUNNING SUTURES WITH RAPID ABSORBABLE SUTURE MATERIAL (POLYGLACTIN 5-0; VICRYL-RAPIDE ®) WERE PLACED TO AVOID BLEEDING FROM THE WOUND EDGE AND FACILITATE WOUND HEALING. SUTURE REMOVAL WAS NOT NECESSARY. POST-OPERATIVE COMPLICATIONS INCLUDED MAJOR WOUND INFECTION (1.2%); WOUND INFLAMMATION OF SMALL SUTURE PARTS (16%) WITHOUT THE NEED OF ANTIBIOTICS; POST-OPERATIVE BLEEDING WITH THE NEED OF INTERVENTION (2.7%); SINGLE SUTURE RUPTURES (19%) WHICH HEALED SECONDARILY WITHOUT COMPLICATIONS; PENETRATION OF SINGLE KNOTS WITHOUT DISCOMFORT FOR THE CHILDREN (43%); SCAR DEHISCENCE IN PARTS OF THE SUTURE (27%); AND SCAR HYPERTROPHY (0.8%). RESULTING SCARS COULD BE IMPROVED BY FURTHER RESECTIONS. ALL TREATED CHILDREN AND THEIR PARENTS FELT INCREASINGLY COMFORTABLE DURING CONSECUTIVE PROCEDURES AND DEVELOPED NORMALLY, BOTH SOMATICALLY AND MENTALLY. NO MELANOMA OCCURRED WITHIN A MEAN OF 8.5 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009463 UNKNOWN VICRYL RAPIDE SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1