BEUDAMED
    FDA Adverse Event Other Summary report: N

    HANKS UTER DILATOR 11/12

    MDR report key: 979396 · Received June 1, 2006

    Report

    Report Number
    1226348-2006-00132
    Event Type
    Other
    Date Received
    June 1, 2006
    Date of Event
    March 24, 2006
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    HDQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    CODMAN HAS BEEN INFORMED THAT THE DEVICE IS NOT AVAILABLE FOR EVAL. A LOT NUMBER HAS BEEN PROVIDED, THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE PERFORMED. WE ANTICIPATE THAT THE REVIEW WILL SHOW THAT THE INSTRUMENT CONFORMED TO ALL SPECIFICATIONS PRIOR TO BEING RELEASED TO STOCK. IF THE REVIEW NOTES ANYTHING OTHERWISE A FOLLOW-UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND/OR SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED TO BE CLOSED.

    Description of Event or Problem · 1

    HOSPITAL REPORTS THAT A PT UNDERWENT AN ULTRASOUND GUIDED CERVICAL DILATION, HYSTEROSCOPY AND D&C POLYPECTOMY. A HANK UTERINE DILATOR SIZE 11/12 WAS USED DURING THE PROCEDURE. FIVE DAYS FOLLOWING PROCEDURE, THE PT REPORTED SHE REMOVED 3 METAL PIECES FROM HER VAGINA. METAL PIECES FORMED A SMALL RING. GYN EQUIPMENT WAS EXAMINED AND A DILATOR SIZE 11/12 WAS FOUND TO BE WITHOUT AN O RING PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HANKS UTER DILATOR 11/12 DILATOR, CERVICAL, FIXED SIZE HDQ CODMAN & SHURTLEFF, INC. NA 023

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other