BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 354599 · Received October 8, 2001

    Report

    Report Number
    2210968-2001-00579
    Event Type
    Injury
    Date Received
    October 8, 2001
    Date of Event
    June 28, 2001
    Report Date
    August 15, 2001
    Manufacturer
    ETHICON, INC. SAN ANGELO
    Product Code
    GAM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT HAD A LAPAROSCOPICALLY ASSISTED TOTAL VAGINAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, AND ANTERIOR AND POSTERIOR COLPORRHAPHY IN 2001. 15 DAYS LATER PT WAS SEEN FOR COMPLAINT OF SUTURE REACTION. SOME SUTURE MATERIAL WAS REMOVED. 21 DAYS LATER PT WAS SEEN FOR OOZING FROM WOUNDS. SUTURE REMNANTS REMOVED AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45219 COATED VICRYL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC. SAN ANGELO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention