BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 7164959 · Received January 4, 2018

    Report

    Report Number
    2210968-2018-70052
    Event Type
    Injury
    Date Received
    January 4, 2018
    Report Date
    December 26, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. WAS THE HEMATOMA RELATED TO ANY ETHICON SUTURE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE MONOCRYL ON SUTURE USED IN THIS PROCEDURE? ARE THE PRODUCT CODE AND LOT NUMBERS AVAILABLE FOR ETHICON DEVICES USED? CAN SPECIFIC PATIENT DEMOGRAPHICS BE PROVIDED FOR THE SUBJECTS OF THIS ARTICLE? IF SO, PLEASE ALSO INCLUDE: PATIENT INITIALS, INITIAL PROCEDURE DATE, PRE-EXISTING CONDITIONS, SPECIFIC MEDICAL/SURGICAL INTERVENTION PER PATIENT. GYNECOL SURG (2016) 13:1¿20258, 279-280. DOI 10.1007/S10397-01 -0965-1. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED IN JOURNAL ARTICLE ¿VAULT COMPLICATIONS FOLLOWING LAPAROSCOPIC HYSTERECTOMIES-EVALUATION OF SUTURE MATERIALS¿ THAT TOTAL LAPAROSCOPIC HYSTERECTOMIES WERE PERFORMED IN 2013 AND SUTURE WAS USED TO CLOSE VAGINAL VAULT. THE PATIENT MAY HAVE EXPERIENCED VAULT GRANULATION AND MAY HAVE BEEN TREATED WITH SILVER NITRATE, MANAGED CONSERVATIVELY OR HAD EXCISION UNDER GENERAL ANAESTHESIA. THE PATIENT MAY HAVE DEVELOPED VAGINAL VAULT HEMATOMA WHICH MAY HAVE BEEN MANAGED CONSERVATIVELY, REQUIRED SURGICAL INTERVENTION AND MAY HAVE REQUIRED BLOOD TRANSFUSION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8141 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention