BEUDAMED
    FDA Adverse Event Summary report: N

    RICHARD-ALLAN / ASPEN SURGICAL PRODUCTS

    MDR report key: 6178467 · Received December 15, 2016

    Report

    Report Number
    1047429-2016-00020
    Date Received
    December 15, 2016
    Date of Event
    November 16, 2016
    Report Date
    December 15, 2016
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    GAB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AVID MEDICAL IS THE MANUFACTURER OF A CUSTOM PROCEDURE TRAY THAT INCLUDES THE FOLLOWING COMPONENT: RICHARD-ALLAN® SUTURE NEEDLE ½ CIRCLE TAPERED 1 MAYO, VENDOR PART # 216706 MANUFACTURED BY ASPEN SURGICAL PRODUCTS INC. AVID MEDICAL RECEIVED A COMPLAINT ON (B)(6) 2016 ORIGINATED BY(B)(6) STATING THAT DURING THE CASE, THE SUTURE NEEDLE BROKE. THE COMPLAINED SUTURE NEEDLE WAS AVAILABLE FOR EVALUATION. AVID MEDICAL ISSUED FORMAL COMPLAINT #(B)(4) TO THE MANUFACTURER ASPEN SURGICAL CONCERNING THE NEEDLES BREAKING DURING SURGERY FOR ITEM NO. 216706, MANUFACTURER LOT# 108419. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828268 RICHARD-ALLAN / ASPEN SURGICAL PRODUCTS DISPOSABLE SUTURE NEEDLE GAB ASPEN SURGICAL PRODUCTS, INC. 216706 108419

    Patients

    Seq Age Sex Outcome Treatment
    1