BEUDAMED
    FDA Adverse Event Death Summary report: N

    JT POSEY COMPANY

    MDR report key: 186231 · Received September 10, 1998

    Report

    Report Number
    186231
    Event Type
    Death
    Date Received
    September 10, 1998
    Date of Event
    June 12, 1998
    Report Date
    September 8, 1998
    Manufacturer
    J T POSEY
    Product Code
    CBH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS ABLE TO REMOVE VELCRO STRIP RESTRAINING TRACHEOSTOMY TUBE ALLOWING FOR IT'S INADVERTENT REMOVAL. CORPORATE HOME HEALTH REP WRITES, "OBVIOUSLY NO PEDIATRIC PT WITH A TRACH SHOULD BE LEFT UNSUPERVISED, BUT A WARNING ON THE POSEY BOX IS PROBABLY A GOOD IDEA. WE ALSO REPORTED THIS TO JCAHO. THEY DETERMINED IT WAS A SUPERVISION ISSUE (PT NOT WATCHED CLOSELY). I ASKED AROUND AND LEARNED OF AT LEAST ONE RESPIRATORY THERAPIST WHO HAD HEARD OF A PEDIATRIC PT UNSTICKING THE VELCRO TRACH TIE, BUT NO INCIDENT OCCURRED. (I HAVE BEEN IN HOMECARE FOR 12 YRS AND HAD NEVER HEARD OF IT). I NOTICE THAT THERE IS NO WARNING ON THE POSEY BOX, BUT THERE IS A WARNING ON THE DALE BOX. (DALE MAKES A SIMILAR PRODUCT-A VELCRO TRACH TIE). THE DALE BOX WARNS NOT TO LEAVE THE PT UNSUPERVISED. I CALLED THE MFR (POSEY) AND DISCUSSED THE ISSUE WITH THEM. THEY INDICATED THEY HAD NEVER HEAD OF ANY SIMILAR SITUATION. (THE PT PULLED OUT HIS TRACH TUBE AFTER "UNSTICKING" THE VELCRO TRACH TIE)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JT POSEY COMPANY TRACH TIES CBH J T POSEY NA H16981975

    Patients

    Seq Age Sex Outcome Treatment
    1 16 MO Death