BEUDAMED
    FDA Adverse Event Summary report: N

    COATED VICRYL

    MDR report key: 7421059 · Received April 10, 2018

    Report

    Report Number
    MW5076411
    Date Received
    April 10, 2018
    Date of Event
    April 5, 2018
    Report Date
    April 9, 2018
    Manufacturer
    ETHICON, INC.
    Product Code
    GAW
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD PACEMAKER PLACEMENT AND WHEN CLOSING THE WOUND WITH CONTINUOUS RUNNING SUTURE, IT WAS NOTICED, BY PHYSICIAN, THAT THE NEEDLE WOULD FID SOME RESISTANCE TO DO THE STITCHES. AFTER A COUPLE OF STITCHES, THE TIP OF THE NEEDLE WAS EXAMINED. IT WAS NOTICED THAT THE VERY TIP OF THE NEEDLE WAS MISSING. THIS WAS PROBABLY 0.5MM OF THE DISTAL TIP OF THE NEEDLE WHEN COMPARED TO A SIMILAR NEEDLE. AFTER THIS, THE SUTURE WAS INTERRUPTED, CUT AND REMOVED. THE PACEMAKER WAS REMOVED FROM THE POCKET AND THE FLUOROSCOPY WAS DONE TO SEE IF A PIECE OF METAL COULD BE IDENTIFIED AND IT COULD NOT. AN IRRIGATION OF THE POCKET WAS ALSO DONE WITH ABUNDANT ANTIBIOTIC SALINE SOLUTION AND THEN THE PACEMAKER WAS REINTRODUCED INTO THE POCKET. THE INCISION WAS CLOSED WITH A DIFFERENT SUTURE WITH THE SAME TYPE OF TECHNIQUE. PATIENT WAS TAKEN TO THE ICU AND A MSI X-RAY WAS PERFORMED AND NEEDLE WAS NOT IDENTIFIED IN THE X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254592 COATED VICRYL SUTURE NEEDLE GAW ETHICON, INC. JL7135

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR