BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL (POLIGLECAPRONE 25) SUTURE

    MDR report key: 285123 · Received July 11, 2000

    Report

    Report Number
    2210968-2000-00239
    Event Type
    Injury
    Date Received
    July 11, 2000
    Report Date
    May 12, 2000
    Manufacturer
    ETHICON, INC. SAN ANGELO
    Product Code
    GAN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT SURGERY IN WHICH MONOCRYL SUTURE WERE USED. THE REPORTER STATED THAT THE SUTURE PACKAGES WERE OPENED AND PLACED AT THE OPERATIVE TABLE WAITING TO BE USED. FOUR DAYS AFTER THE OPERATION, THE WOUND DEHISCED. WHEN THE PT WAS BROUGHT BACK TO THE OPERATING ROOM, THERE WERE NO SUTURE REMNANTS AT THE WOUND SITE. THE PT WAS RESUTURED WITHOUT FURTHER REPORTED COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOCRYL (POLIGLECAPRONE 25) SUTURE SUTURE, ABSORBABLE GAN ETHICON, INC. SAN ANGELO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention