BEUDAMED
    FDA Adverse Event Other Summary report: N

    MARTIN UTERINE

    MDR report key: 3844654 · Received May 7, 2014

    Report

    Report Number
    1416891-2014-00008
    Event Type
    Other
    Date Received
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    ANCHOR PRODUCTS CO.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE FOLLOW-UP CALLS TO THE HEALTH PROFESSIONAL TO OBTAIN MORE INFO FOR THIS EVENT. THE ONLY INFO THAT WAS PROVIDED TO ANCHOR PRODUCTS WAS THE STATEMENT THAT THE DOCTOR DID NOT PRE-DRILL INTO THE BONE PRIOR TO USING THE NEEDLE. THE HEALTH PROFESSIONAL TOLD ANCHOR THAT IT WAS AN INTERNAL ISSUE AND NOT PRODUCT RELATED.

    Description of Event or Problem · 1

    NEEDLE TIP BROKE WHEN IT HIT THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276604 MARTIN UTERINE NONE GCJ ANCHOR PRODUCTS CO. 1860-5DC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK