BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II (POLYDIOXANONE) SUTURE

    MDR report key: 1063433 · Received June 18, 2008

    Report

    Report Number
    2210968-2008-00457
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    May 20, 2008
    Report Date
    May 22, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    GAN
    PMA / PMN Number
    N18331
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 06/18/2008. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADD'L INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PT PRESENTED WITH INDICATIONS OF SUTURE EXTRUSION APPROX TWO MONTHS FOLLOWING A TOTAL HIP REPLACEMENT. THE SURGICAL SITE WAS DESCRIBED AS "CLEAR, PRISTINE TISSUE WITH NO SIGNS OF INFECTION OR INFLAMMATION." THE PT WAS RETURNED TO SURGERY FOR SCAR EXCISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PDS II (POLYDIOXANONE) SUTURE SUTURE, ABSORBABLE GAN ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR