BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACT II ASSISTANT STOOL

    MDR report key: 134594 · Received November 20, 1997

    Report

    Report Number
    1017522-1997-00129
    Event Type
    Malfunction
    Date Received
    November 20, 1997
    Report Date
    November 20, 1997
    Manufacturer
    SIEMENS PELTON & CRANE CO.
    Product Code
    FZM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTAL ASSISTANT

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE DR'S OFFICE THAT A DENTAL ASSISTANT WAS SITTING ON A ACT II ASSISTANT STOOL WHEN THE BOLT WHICH HOLDS THE STOOLS BODY SUPPORT ARM BROKE ALLOWING THE ASSISTANT TO FALL ONTO THE PT. THE DENTAL ASSISTANT CLAIMS THAT SHE NOW HAS BACK PROBLEMS AND IS GOING TO PHYSICAL THERAPY. THE PT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACT II ASSISTANT STOOL DENTAL STOOL FZM SIEMENS PELTON & CRANE CO. E-1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA