BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK ECHOTIP AMNIOCENTESIS NEEDLE

    MDR report key: 1759977 · Received June 2, 2010

    Report

    Report Number
    1825146-2010-00021
    Event Type
    Injury
    Date Received
    June 2, 2010
    Date of Event
    April 24, 2010
    Manufacturer
    COOK UROLOGICAL, INC.
    Product Code
    HIO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES WILL NOT BE RETURNED DUE TO THEM BEING DISCARDED, A PROPER EVALUATION WILL NOT BE PERFORMED. ADDITIONAL INFORMATION IS BEING REQUESTED, UPON RECEIPT OF THE INFORMATION IT WILL BE FORWARDED.

    Description of Event or Problem · 1

    THE DOCTOR AT (B)(6) SWAPPED TO OUR NEEDLES FROM BD IN (B)(6) - SAME NEEDLE GAUGE AND SIZE. SINCE THE SWAP, HE HAS HAD TWO MISCARRIAGES - THE PATIENT DETAILS ARE AS FOLLOWS:((B)(6) 2010): AVERAGE BODY WEIGHT. NUCHAL SCAN READING 4.4 MULTIPLE. CAME IN (B)(6) WITH BLEEDING - LATER RUPTURED MEMBRANE AND IUD (B)(6). I HAVE TRIED TO GET AS MUCH INFORMATION AS POSSIBLE. THE DOCTOR IS THE LONE PRACTITIONER DOING AMNIOS AT (B)(6). HE HAS CHANGED NOTHING AND HAD NO PREVIOUS CASES OF MISCARRIAGE IN 2 YEARS.

    Additional Manufacturer Narrative · 2

    THE DEVICES WILL NOT BE RETURNED DUE TO THEM BEING DISCARDED, A PROPER EVALUATION WILL NOT BE PERFORMED. ADDITIONAL INFORMATION IS BEING REQUESTED, UPON RECEIPT OF THE INFORMATION IT WILL BE FORWARDED.

    Description of Event or Problem · 2

    THE DOCTOR AT (B)(6) SWAPPED TO OUR NEEDLES FROM BD IN (B)(6) - SAME NEEDLE GAUGE AND SIZE. SINCE THE SWAP HE HAS HAD TWO MISCARRIAGES - THE PATIENT DETAILS ARE AS FOLLOWS: PATIENT 2 ((B)(6) 2010): AVERAGE BODY WEIGHT, (B)(6). NUCHAL SCAN READING NORMAL. AS OLDER PATIENT HAD DOWNS RISK OF 1/38. CAME IN (B)(6) WITH MISCARRIAGE. I HAVE TRIED TO GET AS MUCH INFORMATION AS POSSIBLE. THE DOCTOR IS THE LONE PRACTITIONER DOING AMNIOS AT (B)(6). HE HAS CHANGED NOTHING AND HAD NO PREVIOUS CASES OF MISCARRIAGE IN 2 YEARS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK ECHOTIP AMNIOCENTESIS NEEDLE HIO SAMPLER, AMNIOTIC FLUID (AMNIOCENTESIS TRAY) HIO COOK UROLOGICAL, INC. NA U1922861

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR
    2 38 YR