BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DECOMPRESSION TABLE

    MDR report key: 17851353 · Received October 2, 2023

    Report

    Report Number
    3007278668-2022-00001
    Event Type
    Injury
    Date Received
    October 2, 2023
    Date of Event
    July 12, 2019
    Report Date
    March 23, 2022
    Manufacturer
    PIVOTAL HEALTH SOLUTIONS
    Product Code
    ITH
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A HERNIATED DISC IS CAUSED BY COMPRESSION OF THE DISC WHERE THE DECOMPRESSION DOES THE OPPOSITE, APPLIES DISTRACTION. THE REPORTED INJURY IS IMPOSSIBLE TO BE CAUSED BY THE DECOMPRESSION DEVICE, AND THE REPORTING PARTY DID NOT SUGGEST THE DEVICE WAS THE CAUSE. INCORRECT TREATMENT PROTOCOL BY HEALTH PROFESSIONAL WAS THE CAUSE IDENTIFIED, BUT THE DECOMPRESSION TABLE HAD BEEN PART OF THAT PROTOCOL SO AN INCIDENT REPORT WAS SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO THE MANUFACTURER THAT OUR DEVICE WAS PART OF A TREATMENT PROTOCOL FOR A PATIENT BEING TREATED FOR BACK PAIN, SHOULDER PAIN, NECK TIGHTNESS, AND LOWER AND BILATERAL BACK PAIN. AFTER A TREATMENT IN (B)(6) 2019, PERFORMED BY THE ASSISTANT, TREATMENT THAT INVOLVED HEAT FOLLOWED BY DECOMPRESSION, THE PATIENT REPORTED A POP AND EXTREME PAIN IN THE LOWER BACK. THE DOCTOR ASSESSED THE PATIENT AND REPORTEDLY IDENTIFIED THAT THE ASSISTANT HAD INCORRECTLY APPLIED HEAT AND TRACTION. THERE WAS NO REPORT OF ANY MALFUNCTION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1847218 DECOMPRESSION TABLE ITH PIVOTAL HEALTH SOLUTIONS E9011

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other