BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEOAR 10ML

    MDR report key: 8143477 · Received December 7, 2018

    Report

    Report Number
    3008550999-2018-00012
    Event Type
    Injury
    Date Received
    December 7, 2018
    Date of Event
    August 13, 2018
    Report Date
    November 8, 2018
    Manufacturer
    AUGMENIX, INC.
    Product Code
    OVB
    PMA / PMN Number
    DEN140030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS IMPLANTED WITH SPACEOAR HYDROGEL AND FIDUCIALS ON (B)(6) 2018. THE PATIENT WAS PRESCRIBED A PROPHYLACTIC ANTIBIOTIC PRIOR TO THE PROCEDURE, BUT THE PATIENT'S MEDICATION COMPLIANCE IS UNCONFIRMED. THE APPLYING PHYSICIAN INDICATED THAT SPACEOAR APPEARED TO FORM IN THE CORRECT SPACE WITHOUT ANY NOTED ISSUES DURING THE PROCEDURE. IN THE WEEKS FOLLOWING THE PROCEDURE, THE PATIENT WENT THE TO EMERGENCY DEPARTMENT PRESENTING WITH URINARY URGENCY AND RETENTION, PERINEAL PAIN WITH SWELLING AND INFLAMMATION AND EVIDENCE OF A PUS PRODUCING ABSCESS. THE PATIENT WAS EVALUATED BY A UROLOGIST AND A GENERAL SURGEON. INITIAL IMAGING INDICATED GAS FORMATION NEAR THE SCROTUM, AND THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR FURTHER EVALUATION AND TREATMENT. THE TREATING PHYSICIAN MADE AN INCISION FROM JUST ABOVE THE ANUS EXTENDING TO THE LEFT SCROTUM TO DRAIN AND IRRIGATE THE ABSCESS. WHILE IRRIGATING THE SPACE, THE TREATING PHYSICIAN STATED THAT HE APPEARED TO "DISLODGE AND THEN REMOVE A 1-INCH RECTANGLE OF GELATINOUS MATERIAL" FROM BETWEEN THE RECTUM AND PROSTATE. THE GEL IS PRESUMED TO BE SPACEOAR BASED ON SIZE AND LOCATION. THE TREATING PHYSICIAN INDICATED THAT THE RECTUM REMAINED INTACT WITHOUT INJURY OR INFECTION. THE PATIENT IS CURRENTLY HEALING. THE PATIENT HAS A HISTORY OF TYPE II DIABETES AND IS OVERWEIGHT. PLANNED RADIATION TREATMENT HAS BEEN DELAYED UNTIL THE PATIENT IS FULLY HEALED. RESULTS FROM THE CULTURE TAKEN FROM THE ABSCESS HAVE NOT BEEN SHARED WITH AUGMENIX AT THIS TIME. ADDITIONALLY, IMAGES HAVE NOT BEEN PROVIDED TO AUGMENIX PERSONNEL SO LOCATION OF THE GEL AND THE ABSCESS COULD NOT BE CONFIRMED. WITHOUT CULTURE RESULTS OR IMAGES TO CONFIRM LOCATION OF THE GEL TO THE ABSCESS, THE RELATEDNESS OF THIS EVENT TO THE DEVICE COULD NOT BE ASSESSED. REVIEW OF THE DEVICE HISTORY RECORDS FOR LOTS SHIPPED TO THIS SITE INDICATE THAT THE DEVICES WERE MANUFACTURED TO SPECIFICATION. ALL STERILIZATION REQUIREMENTS WERE MET. THE ROOT CAUSE OF THE PATIENT'S PERINEAL ABSCESS COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A PERINEAL ABSCESS IN THE WEEKS FOLLOWING SPACEOAR AND FIDUCIAL PLACEMENT. SURGERY WAS REQUIRED TO DRAIN AND IRRIGATE THE ABSCESS. IT WAS INDICATED THAT SPACEOAR HYDROGEL WAS ALSO REMOVED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    984224 SPACEOAR 10ML HYDROGEL SPACER OVB AUGMENIX, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention