BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE

    MDR report key: 3180446 · Received June 20, 2013

    Report

    Report Number
    2210968-2013-10673
    Event Type
    Injury
    Date Received
    June 20, 2013
    Report Date
    May 27, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) PEDIATRIC PATIENT UNDERWENT A RESECTION LOOP FOR "INTUSSUSCEPTION" AND INTESTINAL ANASTOMOSIS ON (B)(6) 2013 AND SUTURE WAS USED. ON THE FOURTH POST OPERATIVE DAY THE PATIENT EXPERIENCED A WOUND DEHISCENCE OF THE WALL OPENING AND THE ANASTOMOSIS. THE WOUND WAS RE-CLOSED WITH A DIFFERENT SUTURE. THE PATIENT ALSO WAS DIAGNOSED WITH AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280620 VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE SUTURES - ABSORBABLE GAM ETHICON INC. UNK 297789

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention