BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROBAN BENCH,BATH,W/ BACK,KNCKDWN

    MDR report key: 9215295 · Received October 21, 2019

    Report

    Report Number
    1417592-2019-00181
    Event Type
    Malfunction
    Date Received
    October 21, 2019
    Date of Event
    September 21, 2019
    Report Date
    October 21, 2019
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    ILS
    UDI-DI
    10311917158874
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT AFTER GETTING OUT OF THE SHOWER, THE END-USER SAT DOWN ON THE BATH BENCH. PER REPORT, THE END-USER LEANED FORWARD TO APPLY HIS LEFT ANKLE FOOT ORTHOSIS (END-USER HAS HISTORY OF DROP FOOT) AND THE LEFT BACK LEG OF THE BATH BENCH BENT INWARDS AND FOLDED. REPORTEDLY, THE END USER'S LEG CAUGHT UNDER THE CHAIR RESULTING IN HIS ORTHOSIS BEING DAMAGED. IT WAS ADDED THAT WHEN END-USER FELL FROM SITTING ON THE BATH BENCH, END USER HIT HIS HEAD AND FACE ONTO THE FLOOR. ONE TOOTH WAS REPORTEDLY "KNOCKED OUT" AND ANOTHER TOOTH WAS "CHIPPED." IT WAS DENIED THAT END USER WENT TO THE EMERGENCY ROOM OR TO A DENTIST RELATED TO THE REPORTED EVENT. AFTER THE INCIDENT, THE END- USER NOTED THAT HIS ANKLE FOOT ORTHOSIS "FEELS TIGHT" AND THAT REFITTING OF THE ORTHOSIS WAS REQUIRED RELATED TO THE INCIDENT WITH THE BATH BENCH. IT WAS ALSO REPORTED THAT A PHYSICIAN PRESCRIBED END-USER WITH DICLOFENAC (ANTI-INFLAMMATORY DRUG) FOR HIS LEG SWELLING. IT WAS DENIED THAT ANY IMAGING OR TESTS WERE DONE. THE END-USER ALSO REPORTED THAT HIS CHRONIC BACK PAIN HAS EXACERBATED SINCE THE INCIDENT AND THAT CURRENTLY, HE IS USING A TENS (TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION) MACHINE TO RELIEVE THE PAIN. THE BATH BENCH INVOLVED IN THIS INCIDENT WAS USED FOR APPROXIMATELY A MONTH. DUE TO THE REPORTED EVENT AND THE REQUIRED MEDICAL INTERVENTIONS, MEDWATCH IS BEING FILED. THE SAMPLE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. PHOTOS OF THE BATH BENCH WERE SUBMITTED AND THE ISSUE WAS CONFIRMED. A DEFINITIVE ROOT CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED AT THIS TIME. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT END-USER FELL FROM SITTING ON THE BATH BENCH. THE END-USER REPORTEDLY LEANED FORWARD AND THE LEFT BACK LEG OF THE BATH BENCH BENT INWARDS AND FOLDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010738 MICROBAN BENCH,BATH,W/ BACK,KNCKDWN ILS MEDLINE INDUSTRIES INC. 64518120025 10311917158874

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other| R