BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWICE-AS-TOUGH CUFFS FOR STRETCHER

    MDR report key: 1561088 · Received December 11, 2009

    Report

    Report Number
    2020362-2009-00721
    Event Type
    Injury
    Date Received
    December 11, 2009
    Report Date
    November 11, 2009
    Manufacturer
    POSEY S. DE R. L. DE C.V.
    Product Code
    FMQ
    PMA / PMN Number
    K963413
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED TWO LOT NUMBERS, BUT DID NOT KNOW WHICH ONE WAS USED ON THE PATIENT. TWO LOT NUMBERS WERE PROVIDED: 08253 AND 08234. DISLOCATED RIGHT SHOULDER. THERE WAS NO DAMAGE OR PRODUCT PROBLEM OBSERVED WITH THE DEVICE PRIOR TO USE. THE CUSTOMER DID NOT RETURN THE PRODUCT FOR EVALUATION AND STATED THAT THE PRODUCT HAS BEEN DISCARDED. THE REPORTER STATED THAT THERE WAS NO PRODUCT DAMAGE OR PRODUCT PROBLEM OBSERVED WHEN THE RESTRAINT WAS APPLIED TO THE PATIENT BEFORE THE INCIDENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE PRODUCT WAS BEING USED AS A 4 POINT RESTRAINT ON A PATIENT THAT WAS ADMITTED TO THE HOSPITAL. THE PATIENT HAD A HISTORY OF MENTAL ILLNESS AND VIOLENCE. AFTER BEING RESTRAINED, THE PATIENT MANAGED TO FREE HIS RIGHT ARM BY CHEWING ON THE RESTRAINT AND AFTERWARDS WAS ABLE TO FREE HIMSELF ROM THE RESTRAIN AND STOOD UP. THE PATIENT MANAGED TO ASSAULT FIVE STAFF MEMBERS. TWO OF THE STAFF MEMBERS WERE INJURED. ONE STAFF MEMBER WAS KNOCKED UNCONSCIOUS AND RECEIVED A BROKEN NOSE. THE SECOND STAFF MEMBER SUFFERED A DISLOCATED RIGHT SHOULDER. THIS REPORT IS FOR THE SECOND STAFF MEMBER THAT SUFFERED A DISLOCATED RIGHT SHOULDER. THE FIRST MEDWATCH REPORT IS BEING SUBMITTED FOR THE OTHER STAFF MEMBER. (REFERENCE MDR 2020362-2009-00720). THE INJURED STAFF MEMBER WAS ADMITTED TO THE SAME FACILITY HOSPITAL ER DEPARTMENT IN 2009 AND WAS GIVEN AN X-RAY. HE WAS DIAGNOSED WITH A DISLOCATED RIGHT SHOULDER. AFTERWARDS THE STAFF MEMBER WAS RELEASED FROM THE ER DEPARTMENT. THE REPORTER WAS CONTACTED THE FOLLOWING MONTH AND HE STATED THAT THIS STAFF MEMBER RETURNED TO WORK AFTER TWO WEEKS AND IS CURRENTLY DOING OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TWICE-AS-TOUGH CUFFS FOR STRETCHER FMQ POSEY S. DE R. L. DE C.V. 2750 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization