BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORMALDEHYDE REUSE CART

    MDR report key: 30223 · Received February 13, 1996

    Report

    Report Number
    30223
    Event Type
    Injury
    Date Received
    February 13, 1996
    Date of Event
    January 19, 1996
    Report Date
    February 13, 1996
    Manufacturer
    RENAL SCIENTIFIC SERVICES
    Product Code
    LIF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS IS A FOLLOW UP REPORT TO CORRECT SOME MISINFORMATION REGARDING UF REP #012513-1996-0006/MF REP #1223466-1996-00001. A FORMALDEHYDE SPILL-PRESUMED 37%-OCCURRED IN THIS DIALYSIS FACILITY. TWO SOURCES WERE IDENTIFIED-A LEAKING SEAL ON A REUSE CART AND A SPILL DOWN THE BACK OF A SHELVING UNIT. THE UNIT WAS EVACUATED, BUT NO ONE WAS SENT TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORMALDEHYDE REUSE CART MANUAL REUSE CART LIF RENAL SCIENTIFIC SERVICES 10,000-1

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention