BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II (POLYDIOXANONE) SUTURE

    MDR report key: 6642034 · Received June 14, 2017

    Report

    Report Number
    2210968-2017-32545
    Event Type
    Injury
    Date Received
    June 14, 2017
    Date of Event
    April 20, 2017
    Report Date
    April 20, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: YOU REPORTED THAT THE SUTURE FAILED. HOW EXACTLY DID THE SUTURE FAIL? SUTURE WAS BROKEN SO THEY NEEDED TO RE OPERATE. IF REOPERATION WAS PERFORMED ON (B)(6), PLEASE PROVIDE DATE, WHAT TYPE OF PROCEDURE AND SURGICAL FINDINGS? ABDOMINAL HYSTERECTOMY WAS THE ORIGINAL PROCEDURE. HOW IS THE PATIENT TODAY? DNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ABDOMINAL HYSTERECTOMY PROCEDURE ON UNKNOWN DATE AND THE SUTURE WAS USED. IT WAS ALSO REPORTED THAT THE SUTURE BROKE AND THE PATIENT UNDERWENT A RE-OPERATION ON (B)(6)2017. ADDITIONAL INFORMATION WILL BE REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422978 PDS II (POLYDIOXANONE) SUTURE SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. UNK KJZ069

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention