BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910)

    MDR report key: 3072708 · Received April 23, 2013

    Report

    Report Number
    2210968-2013-04291
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    April 2, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A DISTAL GASTRECTOMY PROCEDURE ON (B)(6) 2013. THE PATIENT DEVELOPED A SURGICAL SITE INFECTION BETWEEN THE SURFACE OF SKIN AND UNDER THE DEEP PART OF THE SKIN AND IS UNDERGOING DRAINAGE. CURRENTLY, THE PATIENT FEELS FINE. THE SURGEON OPINES THAT A POSSIBLE CAUSE FOR THE INFECTION IS THAT A CHANNEL BETWEEN THE ABDOMINAL CAVITY AND THE OUTSIDE OF THE BODY DEVELOPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174588 COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE, ABSORBABLE GAM ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention