BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RICHARD ALLAN SURGICAL NEEDLE

    MDR report key: 2890819 · Received November 20, 2012

    Report

    Report Number
    1836161-2012-00011
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 20, 2012
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    GAB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD, RESULTS AND CONCLUSION: WAITING FOR SAMPLES TO BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    WHILE PERFORMING OCULAR SURGERY, SUTURING THE RIGHT LOWER LID, THE NEEDLE TIP BROKE. X-RAYS WERE TAKEN, NO NEEDLE PIECES WERE FOUND. A MAGNETIC NEEDLE FINDER USED ON THE FLOOR FOUND METAL PIECES. HOWEVER, UNSURE IF THE METAL PIECE WERE PART OF THE BROKEN NEEDLE TIP. PART NUMBER: 215405. DESCRIPTION: NEEDLE HALF CIRCLE REVERSE CUTTING LANES CLEFT PALATE. LOT NUMBER: 52670000

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RICHARD ALLAN SURGICAL NEEDLE EYED SURGICAL NEEDLE GAB ASPEN SURGICAL PRODUCTS, INC. 215405 52670000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention