BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROMARK BREAST BIOPSY SITE MARKER

    MDR report key: 8897042 · Received August 15, 2019

    Report

    Report Number
    3008492462-2019-00040
    Event Type
    Injury
    Date Received
    August 15, 2019
    Date of Event
    July 18, 2019
    Report Date
    August 15, 2019
    Manufacturer
    DEVICOR MEDICAL PRODUCTS, INC.
    Product Code
    NEU
    UDI-DI
    00841911101482
    PMA / PMN Number
    K060769
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE HYDROMARK BREAST BIOPSY SITE MARKER IS USED TO MARK TISSUE DURING A PERCUTANEOUS BREAST BIOPSY PROCEDURE, BE VISIBLE UNDER ULTRASOUND FOR AT LEAST 6 WEEK, AND BE PERMANENTLY VISIBLE BY X-RAY AND MRI. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION, WHICH PREVENTS A FULL INVESTIGATION AND ANALYSIS OF A ROOT CAUSE AT THIS TIME. HOWEVER, THIS FAILURE MODE HAS BEEN IDENTIFIED IN THE RISK MANAGEMENT FILE FOR THE EFFECTS OF POTENTIAL FOREIGN BODY REACTION WITH A POTENTIAL FOR INJURY TO THE PATIENT AND/OR USER. FOLLOW UP MEDICAL INTERVENTION MAY BE NECESSARY. ALTHOUGH IT COULD NOT BE CONCLUDED THAT OUR DEVICE CAUSED OR CONTRIBUTED TO THIS EVENT, THROUGH EVALUATION BY OUR MEDICAL ADVISOR ON SIMILAR EVENTS, THIS HAS BEEN DETERMINED TO BE REPORTABLE PURSUANT TO 21 CFR 803.

    Description of Event or Problem · 1

    DEVICOR MEDICAL PRODUCTS, INC. RECEIVED A REPORT FROM THE USER FACILITY STATING, A BUTTERFLY SHAPED TITANIUM HYDROMARK MARKER WAS PLACED IN (B)(6) 2018. THE PATIENT COMPLAINED OF PAIN SINCE THAT TIME AND REQUESTED REMOVAL OF THE MARKER. THE CLIP WAS REMOVED (B)(6) 2019. THIS HAS BEEN DOCUMENTED IN OUR SYSTEM AS RECORD # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692909 HYDROMARK BREAST BIOPSY SITE MARKER BIOPSY SITE MARKER NEU DEVICOR MEDICAL PRODUCTS, INC. 4010-02-15-T4 200044907 00841911101482

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention