BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE

    MDR report key: 3253772 · Received July 30, 2013

    Report

    Report Number
    2210968-2013-14993
    Event Type
    Injury
    Date Received
    July 30, 2013
    Report Date
    July 15, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 A PATIENT UNDERWENT A UROGYNECOLOGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT EXPERIENCED A REACTION MONTHS AFTER THE SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356544 MONOCRYL POLIGLECAPRONE 25 SUTURE SUTURES - ABSORBABLE GAN ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention