BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPAK(R) BONE GROWTH STIMULATOR

    MDR report key: 6666297 · Received June 26, 2017

    Report

    Report Number
    0002242816-2017-00024
    Event Type
    Injury
    Date Received
    June 26, 2017
    Report Date
    June 26, 2017
    Manufacturer
    EBI, LLC.
    Product Code
    LOF
    PMA / PMN Number
    PP850022
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FULL NUMBER: P850022/S017. THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. THE PRODUCT WAS DISCARDED BY THE PATIENT AND THEREFORE WILL NOT BE RETURNED FOR AN EVALUATION. BECAUSE THE LOT NUMBER IS UNKNOWN, THE DEVICE HISTORY RECORDS COULD NOT BE PULLED AND REVIEWED. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. THIS IS REPORT ONE OF TWO FOR THE SAME EVENT. REPORT TWO OF TWO IS REPORTED ON MFR #:0002242816-2017-00025.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED THE ORTHOPAK IN (B)(6) 2017 FOR HER CLAVICLE. A WHILE AGO, THE PATIENT STARTED EXPERIENCING A RASH WITH REDNESS WHILE USING THE 72 R ELECTRODES AND COVER PATCHES. WHEN THE PATIENT TRIED USING THE ELECTRODES WITHOUT THE COVER PATCHES SHE STILL EXPERIENCED THE RASH AND REDNESS. AT FIRST, THE PATIENT CHANGED THE ELECTRODES EVERY THREE TO FOUR DAYS. WHEN THE RASH WAS DISCOVERED, SHE STARTED CHANGING THEM EVERY DAY. THE RASH WENT FROM HER HAIRLINE DOWN TO HER WAIST. SHE CONSULTED HER DERMATOLOGIST BECAUSE THE RASH WOULD NOT GO AWAY. HER DERMATOLOGIST DIAGNOSED HER WITH CONTACT DERMATITIS AND PRESCRIBED PROTOPIC CREAM AND ALEVICYN DERMAL SPRAY. IT HAD BEEN A MONTH SINCE SHE STOPPED USING THE UNIT AND THE DERMATITIS STARTED CLEARING UP DUE TO THE PRESCRIBED MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448435 ORTHOPAK(R) BONE GROWTH STIMULATOR STIMULATOR, BONE GROWTH, NON-INVASIVE, SOFT-TOUCH ELECTRODES, 72R LOF EBI, LLC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention