BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURAD

    MDR report key: 14873880 · Received June 30, 2022

    Report

    Report Number
    14873880
    Event Type
    Malfunction
    Date Received
    June 30, 2022
    Date of Event
    June 6, 2022
    Report Date
    June 22, 2022
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    FRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CURAD PLAIN PACKING STRIP SEALED BOTTLE (1 IN X 5 YD), WAS FOUND TO BE EMPTY ONCE OPENED. SURGEON SAID THIS IS THE SECOND BOTTLE OF PACKING STRIP THAT HAS BE DEVOID OF CONTENTS TODAY. REF# (B)(4), LOT# 6052011018. MANUFACTURER RESPONSE FOR PLAIN PACKING STRIP, CURAD PLAIN PACKING STRIP (1 IN X 5 YD) (PER SITE REPORTER) ESCALATED TO MEDLINE REP WHO OPENED INTERNAL COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2890908 CURAD DRESSING, WOUND, DRUG FRO MEDLINE INDUSTRIES, LP 6052011018

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other