BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEOAR SYSTEM

    MDR report key: 6567901 · Received May 15, 2017

    Report

    Report Number
    3008550999-2017-00002
    Event Type
    Injury
    Date Received
    May 15, 2017
    Date of Event
    April 12, 2017
    Report Date
    April 12, 2017
    Manufacturer
    AUGMENIX, INC
    Product Code
    OVB
    UDI-DI
    00864661000102
    PMA / PMN Number
    DEN140030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AUGMENIX MEDICAL CONSULTANT REVIEWED MR IMAGES WITH COMPLAINANT PHYSICIAN ON APRIL 14, 2017. COMPLAINANT PHYSICIAN STATED PATIENT HAS A PRETTY HIGH RISK DISEASE. HE GOT A CS SEED IMPLANT WITH SPACEOAR PLACEMENT AT TIME OF IMPLANT FOUR WEEKS AGO. COMPLAINANT PHYSICIAN SAID IMAGING SHOWED GOOD SPACEOAR PLACEMENT AND RECTAL SEPARATION. NO PERINEAL PRESSURE OR PAIN BUT SUPER PAINFUL RECTAL EXAM AND VERY PAINFUL WITH EACH BOWEL TRANSIT. NO FEVERS OR ELEVATED WBC. TREATING PHYSICIAN STARTED HIM ON CIPRO AND FLAGYL. PATIENT IS SLIGHTLY GETTING BETTER BUT HE DOESN'T THINK ITS FROM ABX. GAS ON CBCT IS MAIN REASON HE IS THINKING INFECTION. IN FOLLOW-UP WITH COMPLAINANT PHYSICIAN, HE HAD INFORMED US THAT PATIENT PAIN HAS GOTTEN BETTER WITH ANTIBIOTICS. PATIENT HAD COMPLETED TREATMENT AND RETURNED TO WORK. AT LAST CBCT AIR WAS STILL PRESENT AND NOT OBVIOUSLY DIFFERENT. STERILIZATION RECORDS WERE REVIEWED AND WERE WITHIN SPECIFICATIONS. NO ADDITIONAL INFECTION COMPLAINTS WERE RECEIVED ASSOCIATED WITH THIS PRODUCTION LOT OF (B)(4) UNITS RELEASED FOR DISTRIBUTION AUGUST 19, 2016.

    Description of Event or Problem · 1

    COMPLAINANT PHYSICIAN NOTIFIED AUGMENIX, INC. THAT PATIENT WHO HAD A SPACE OAR AND SEED IMPLANT WAS EXPERIENCING RECTAL PAIN AND THERE IS ALSO UNUSUAL AIR IN SPACE. COMPLAINANT PHYSICIAN IS WORRIED ABOUT INFECTION AND WOULD LIKE TO SPEAK WITH SOMEONE ABOUT IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348724 SPACEOAR SYSTEM HYDROGEL SPACER OVB AUGMENIX, INC 11071601 00864661000102

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention