BEUDAMED
    FDA Adverse Event Summary report: N

    WALLACH PAPETTE KIT

    MDR report key: 5554309 · Received April 7, 2016

    Report

    Report Number
    1222780-2016-00086
    Date Received
    April 7, 2016
    Report Date
    April 7, 2016
    Manufacturer
    COOPERSURGICAL INC.
    Product Code
    HFE
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOLOGIC RECEIVED NOTIFICATION FROM A CUSTOMER IN THE US WHOSE CLIENT USED A WALLACH PAPETTE COLLECTION DEVICE (COOPERSURGICAL P/N 908006, HOLOGIC P/N 70101-001) WHERE THE BRISTLE HEADS DETACHED INSIDE A PATIENT REQUIRING REMOVAL BY PRACTITIONER. SUBSEQUENT DEVICES WHICH COME IN WRAPPED IN (B)(6) BAGS, WERE USED FROM THIS SAME LOT NUMBER WITHOUT ANY PROBLEM. HOLOGIC WAS INFORMED AS A PRECAUTION, THIS LOT WOULD BE REMOVED TO INSURE PATIENT SAFETY AND BE RETURNED TO HOLOGIC FOR REPLACEMENT. THE LOT NUMBER WAS NOT KNOWN AT THE TIME OF THE REPORT BUT WOULD BE PROVIDED TO HOLOGIC AT A LATER TIME. THE WALLACH PAPETTE COLLECTION DEVICE IS NOT MANUFACTURED BY HOLOGIC. HOLOGIC HAS NOTIFIED THE MANUFACTURER COOPERSURGICAL INC. OF THIS INCIDENT. HOLOGIC CONSIDERS THIS A REPORTABLE EVEN SINCE IT REQUIRED MEDICAL INTERVENTION TO PREVENT HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213318 WALLACH PAPETTE KIT WALLACH PAPETTE KIT HFE COOPERSURGICAL INC. 908006

    Patients

    Seq Age Sex Outcome Treatment
    1 Other