BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE

    MDR report key: 4903660 · Received July 9, 2015

    Report

    Report Number
    2210968-2015-08178
    Event Type
    Injury
    Date Received
    July 9, 2015
    Report Date
    June 23, 2015
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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 THE PATIENT UNDERWENT AN UNKNOWN SURGICAL PROCEDURE ON UNKNOWN DATE AND SUTURE WAS USED IN SUBCUTANEOUS LAYER BELOW SKIN LAYER. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED SLIGHT DEHISCENCE OF WOUND, INFLAMMATORY RESPONSE WITH HIGHER CRP READING AND SUTURE SURFACING THROUGH THE SKIN. THE SWAB OF WOUND REVEALED NO MICROORGANISMS GREW AND NO SURGICAL SITE INFECTION (SSI). ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445845 VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention