BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    17G WALLACE OOCYTE RCVRY

    MDR report key: 15833292 · Received November 21, 2022

    Report

    Report Number
    1216677-2022-00307
    Event Type
    Malfunction
    Date Received
    November 21, 2022
    Date of Event
    November 10, 2022
    Report Date
    November 21, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    KOC
    PMA / PMN Number
    K012068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO SECTIONS D1 AND D2 COOPERSURGICAL, INC. IS CURRENLTY INVESTIGATING THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL, INC. IS CURRENLTY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 0

    *WHAT ARE THE DETAILS OF THE COMPLAINT? IS THERE ANYTHING ELSE? DR. (B)(6), GYNECOLOGIST AND OWNER OF THE (B)(6), EXPRESSED EXTREME DISAPPOINTMENT ABOUT THE YIELD OF THE ONS1733-750 PICKUP NEEDLES (WHICH WE SENT AS A SUBSTITUTION FOR THE BACKORDER OF ONS1733 THAT HE FINDS GREAT). ACTUALLY HE RETURNED 4 OUT OF 10 PIECES OF THE PACKAGE, SINCE THE OTHER 6 HAVE ALL CAUSED HEAVY BLEEDING AND HE EVEN HAD TO GIVE STITCHES (THAT HE NEVER GAVE IN OVER 30 YEARS). ACCORDING TO THE DOCTOR, THE ONS1733-750 DO NOT DIFFER FROM THE ONS1733 ONLY IN THE LENGTH OF THE CONNECTION TUBE BUT ALSO IN THE SHARP PART OF THE NEEDLE. ADDITIONAL COMPLAINTS: 2022-11-0000364, 2022-11-0000365, 2022-11-0000366, 2022-11-0000367, 2022-11-0000368

    Description of Event or Problem · 0

    *WHAT ARE THE DETAILS OF THE COMPLAINT? IS THERE ANYTHING ELSE? DR. (B)(6), GYNECOLOGIST AND OWNER OF (B)(6), EXPRESSED EXTREME DISAPPOINTMENT ABOUT THE YIELD OF THE ONS1733-750 PICKUP NEEDLES (WHICH WE SENT AS A SUBSTITUTION FOR THE BACKORDER OF ONS1733 THAT HE FINDS GREAT). ACTUALLY HE RETURNED 4 OUT OF 10 PIECES OF THE PACKAGE, SINCE THE OTHER 6 HAVE ALL CAUSED HEAVY BLEEDING AND HE EVEN HAD TO GIVE STITCHES (THAT HE NEVER GAVE IN OVER 30 YEARS). ACCORDING TO THE DOCTOR, THE ONS1733-750 DO NOT DIFFER FROM THE ONS1733 ONLY IN THE LENGTH OF THE CONNECTION TUBE BUT ALSO IN THE SHARP PART OF THE NEEDLE. ADDITIONAL COMPLAINTS: (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1385221 17G WALLACE OOCYTE RCVRY 17G WALLACE OOCYTE RCVRY KOC COOPERSURGICAL, INC. ONS1733-750 619004635

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other