BEUDAMED
    FDA Adverse Event Other Summary report: N

    BARIMAXXII

    MDR report key: 3452821 · Received October 28, 2013

    Report

    Report Number
    3010048749-2013-00037
    Event Type
    Other
    Date Received
    October 28, 2013
    Date of Event
    October 15, 2013
    Report Date
    October 15, 2013
    Manufacturer
    ARJOHUNTLEIGH INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED BY THE MFR ARJOHUNTLEIGH, INC. PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FROM THE MFG SITE KINETIC CONCEPTS, INC. AS OF (B)(4) 2012, COMPLAINTS RELATED TO THIS PRODUCT ARE TO BE HANDLED BY ARJOHUNTLEIGH, INC. ADD'L INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFR INVESTIGATION.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO ARJOHUNTLEIGH BY THE NURSE: ON (B)(6) 2013, A TRANSPORTER WAS TRANSPORTING THE PATIENT AND WHILE DOING SO, THE HEADBOARD CAME OFF OF THE BED. THE TRANSPORTER WAS UNABLE TO MAINTAIN PROPER BODY MECHANICS WHEN THE HEAD BOARD CAME OFF AND SUSTAINED MINOR BACK STRAIN THAT REQUIRED PHYSICAL THERAPY AND ANTI-INFLAMMATORY MEDICATION. THE TRANSPORT'S BACK STRAIN HAS SINCE RESOLVED. THIS IS BEING REPORTED BY ARJOHUNTLEIGH DUE TO AN ABUNDANCE OF CAUTION AS NORMALLY BACK STRAIN IS CONSIDERED A MINOR INJURY. THE BED DID NOT MALFUNCTION AS THE HEADBOARD IS DESIGNED TO COME OFF AS A SAFETY MEASURE FOR EMERGENCY SITUATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551143 BARIMAXXII FNL ARJOHUNTLEIGH INC. 310400

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention