BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNCLEAR-SMARTLIPO/APOLLO - THE BELOW IS APOLLO'S

    MDR report key: 4308686 · Received October 14, 2014

    Report

    Report Number
    3008753275-2014-00001
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 17, 2014
    Manufacturer
    POLLOGEN LTD
    Product Code
    GEI
    PMA / PMN Number
    K111026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE APPEARS TO HAVE BEEN USED OFF-LABEL IN THE ABDOMEN FOLLOWING SURGICAL LIPOSUCTION AND IT IS UNCLEAR WHETHER THE DEVICE CAUSED OR CONTRIBUTED TO THE INJURY. THE COMPANY'S INVESTIGATION IS ONGOING AND POLLOGEN WILL UPDATE THE MDR SHOULD ADDITIONAL INFO BE OBTAINED. POLLOGEN IS REPORTED THIS MDR WITH THE INFORMATION CURRENTLY AVAILABLE IN AN ABUNDANCE OF CAUTION. THE APOLLO DEVICE IS AVAILABLE FOR EXAMINATION. LUMIER'S TECH WILL CHECK THE DEVICE IN THE CLINIC AND SEND A DETAILED REPORT TO POLLOGEN. THE CLINIC INSISTS THAT THE TECH WILL ARRIVE TO THE CLINIC AS THEY ARE WORKING WITH THE DEVICE. POLLOGEN WILL UPDATE THE MDR ONCE ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2014 THE PT WENT THROUGH SMARTLIPO SURGERY BY THE TREATING PHYSICIAN. ON (B)(6) 2014 THE PT RETURNED FOR FOLLOW-UP AND HAD HER FIRST TRIPOLLAR RADIO-FREQUENCY PROCEDURE ON THE SAME DAY. ON (B)(6), THE PT SENT AN E-MAIL SHOWING PICTURES OF A BURN WOUND TO THE TREATING PHYSICIAN BUT WAS UNABLE TO COME IN FOR AN OFFICE VISIT AT THAT TIME. SHE CONTINUED TO PROVIDE E-MAIL UPDATES WITH PICTURES SHOWING THE EVOLUTION OF HER BURN WOUND BUT WAS UNABLE TO COME IN FOR AN OFFICE VISIT DUE TO BEING OUT-OF-TOWN. ON (B)(6) SHE RETURNED FOR A FOLLOW UP VISIT AND THE TREATING PHYSICIAN TREATED HER WITH A COMBINATION OF PLATELET-RICH PLASMA (PRP) AND ACELL'S MATRISTEM MICROMATRIX AND WOUND MATRIX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651970 UNCLEAR-SMARTLIPO/APOLLO - THE BELOW IS APOLLO'S APOLLO GEI POLLOGEN LTD 30002000US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention SMARTLIPO TREATMENT 8 DAYS PRIOR TO APOLLO,| TREATMENT BEFORE COMPLETE HEALING.