BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEOAR SYSTEM

    MDR report key: 6183158 · Received December 16, 2016

    Report

    Report Number
    3008550999-2016-00001
    Event Type
    Injury
    Date Received
    December 16, 2016
    Date of Event
    October 27, 2016
    Report Date
    November 14, 2016
    Manufacturer
    AUGMENIX, INC
    Product Code
    OVB
    UDI-DI
    00864661000102
    PMA / PMN Number
    DEN140030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STERILIZATION RECORDS WERE REVIEWED AND WERE WITHIN SPECIFICATION. NO ADDITIONAL INFECTION COMPLAINTS WERE RECEIVED ASSOCIATED WITH THIS PRODUCTION LOT OF (B)(4) UNITS RELEASED FOR DISTRIBUTION MAY 20, 2016. PHYSICIAN BELIEVES THE CATHETERS OR SPACEOAR NEEDLE MUST HAVE GOTTEN CONTAMINATED AT TIME OF PROCEDURE OR DURING HDR TREATMENT. STAFF TURNOVER IN OR HAS CREATED NEW PEOPLE WITH LESS FAMILIAR SEMI-STERILE PROCEDURE. POTENTIAL FOR CONTAMINATION WITH DECREASED FAMILIARITY OF HDR PROCEDURE. ALSO THE HOSPITAL HAD JUST CHANGED THEIR STERILIZATION PACKAGING FOR THE HDR CATHETERS TO A NEW "BUBBLE PACK" AND PERHAPS THIS NEW METHOD FOR PREPARING THE HDR CATHETERS COULD HAVE HAD A LAPSE IN STERILIZATION. ADDITIONALLY IT WAS NOTED THE PATIENT HAD A SUB-STANDARD HYGIENE AND THIS COULD HAVE INCREASED THE POTENTIAL FOR THIS OUTCOME.

    Description of Event or Problem · 1

    PHYSICIAN CALLED AUGMENIX TO REQUEST INFORMATION ON OUR HISTORICAL INFECTION RATE ASSOCIATED WITH SPACEOAR. HE HAD A PATIENT WITH AN ACTIVE INFECTION THAT HE TREATED POST HIGH DOSE RADIATION (HDR) AND SPACEOAR PLACEMENT. HIS THOUGHTS WERE THAT THE INFECTION WAS NOT DIRECTLY RELATED TO SPACEOAR GEL. ONE WEEK AFTER TREATMENT-PATIENT PRESENTED WITH TRANSPERINEAL PAIN. MEDROL DOSE PACK WAS PRESCRIBED AND PAIN WENT AWAY. TWO WEEKS AFTER TREATMENT- PATIENT RE-PRESENTED WITH TRANSPERINEAL PAIN. MEDROL DOSE PACK PRESCRIBED A SECOND TIME AND PAIN WENT AWAY. ON (B)(6) 2016 - TOOK MRI AND CONFIRMED SPACEOAR HYDROGEL WAS BETWEEN RECTUM AND PROSTATE. RECTAL WALL THICKENING IS PRESENT ON MRI AND HYPER INTENSE SIGNAL IS HYDROGEL, NOT ABSCESS. PATIENT WAS HAVING PERSISTENT PAIN IN THE PERINEUM WHICH IS WORSENING. PAIN PERSISTENT AND MILDLY ELEVATED WHITE BLOOD COUNT TO 10.5. THIS ELEVATED COUNT THOUGHT TO BE DUE TO THE PRESCRIBED STEROIDS. ON (B)(6) 2016 - PATIENT PRESENTS WITH WHITE BLOOD COUNT ELEVATED UP TO 17. PATIENT IS GIVEN A CONTRAST ENHANCED CT SCAN TO CHECK FOR RECTAL WALL PERFORATION. NO PERFORATION IS OBSERVED. URETHROGRAM PERFORMED TO CONFIRM NO FISSURES WITHIN URETHRA, NONE OBSERVED. CT SCAN REVEALS SOME AIR COLLECTIONS BETWEEN THE PROSTATE AND THE RECTUM AND THE AREA OF THE PENILE BULB REGION. PHYSICIAN VERY CONCERNED ABOUT INFECTION. ORAL ANTIBIOTICS PRESCRIBED AT THIS TIME ARE CIPORO, FLAGIL AND BACTERIN. ON (B)(6) 2016 - PATIENTS PERINEUM PAIN IS WORSENING. AN ADDITIONAL CT SCAN IS TAKEN AND THE AIR COLLECTION DIAGNOSED (B)(6) REMAINS IN PLACE, NO ADDITIONAL AIR SEEMS PRESENT. WHITE COUNT IS DOWN FROM 17 TO 14 TODAY. PATIENT ADMITTED AND TRANS-PERINEAL INCISION ALLOWED FOR 20CC PUS TO BE EXTRACTED. ON (B)(6) 2016 - PHYSICIAN INDICATED THAT PATIENT IS DOING WELL AND ASKING TO BE DISCHARGED. THEY WERE KEEPING HIM A BIT LONGER ON IV FLUIDS, MEDS, AND MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834322 SPACEOAR SYSTEM HYDROGEL SPACER OVB AUGMENIX, INC 07251601 00864661000102

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R