BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEOAR SYSTEM

    MDR report key: 6194824 · Received December 21, 2016

    Report

    Report Number
    3008550999-2016-00002
    Event Type
    Injury
    Date Received
    December 21, 2016
    Date of Event
    January 19, 2016
    Report Date
    November 22, 2016
    Manufacturer
    AUGMENIX, INC
    Product Code
    OVB
    UDI-DI
    00864661000010
    PMA / PMN Number
    DEN140030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SPACEOAR SYSTEM HYDROGEL IMPLANTED (B)(6) 2015. PROCEDURE UNREMARKABLE ACCORDING TO COMPLAINANT. CLINICAL STUDY DEMONSTRATED HYDROGEL IS ABSORBED APPROXIMATELY 6 MONTHS POST IMPLANTATION. ONSET OF INITIAL SYMPTOMS OCCURRED 6 MONTHS POST IMPLANTATION; AND ALLEGED COLOSTOMY OCCURED ABOUT 12 MONTHS POST IMPLANT, 6 MONTHS AFTER HYDROGEL IS EXPECTED TO BE ABSORBED / NOT PRESENT. ON DEC 12, 2016 MRIS PROVIDED BY COMPLAINANT WERE REVIEWED BY AUGMENIX AND MEDICAL CONSULTANT PHYSICIAN. THE (B)(6) 2015 POST IMPLANT IMAGES SHOW SPACEOAR WAS PARTIALLY OFFSET TO RIGHT SIDE OF PATIENT. THE (B)(6) 2016 MRI SHOW SOME INTRAPROSTATIC PROTEINACEOUS MATERIAL. THERE IS NO HYDROGEL PRESENT. THE (B)(6) 2016 MRIS SHOW PUBIC SYMPHYSIS EDEMA AND MRIS FROM (B)(6) 2016 SHOW HYPERINTENSITY PRESENT ON RIGHT SIDE OF PROSTATE. INVESTIGATION IS ONGOING. NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE COMPLAINANT PHYSICIAN: PATIENT DID NOT HAVE ANY PRIOR RECTAL SURGERIES. PATIENT DID NOT HAVE ANY PRIOR CHEMOTHERAPY AND/OR RADIATION THERAPY. FIDUCIAL MARKERS WERE PLACED. PATIENT DID NOT RECEIVE HIGH DOSE RADIATION THERAPY. MOST RECENT PSA WAS LOWER THAT PRE-TREATMENT. PATIENT DID NOT HAVE AN ELEVATED WHITE CELL COUNT COLOSTOMY PROCEDURE WAS PERFORMED ON (B)(6) 2016. PATIENT DID NOT HAVE ANY CONSTIPATION ISSUES.

    Description of Event or Problem · 1

    ON NOV 22, 2016 RECEIVED VERIFICATION FROM COMPLAINANT PHYSICIAN THAT PATIENT HAD ALLEGED COLOSTOMY PROCEDURE SOMETIME BETWEEN (B)(6) 2016. ON DEC 2 , 2016 - IN FOLLOW-UP COMMUNICATION WITH THE COMPLAINANT PHYSICIAN THE FOLLOWING CHRONOLOGY OF EVENTS WAS PROVIDED: ON (B)(6) 2015 - SPACEOAR HYDROGEL WAS PLACED AND PROCEDURE WENT WELL PER HYDROGEL APPLIER. ON (B)(6) 2015 - PATIENT BEGAN RADIATION THERAPY. ON (B)(6) 2015 - PATIENT COMPLETED RADIATION THERAPY. ON (B)(6) 2016 - PATIENT HAD POST BOWEL MOVEMENT PAIN. PATIENT WAS REFERRED TO COLORECTAL SURGEON AND DIAGNOSED WITH PROCTITIS. PATIENT WAS PRESCRIBED ANTIBIOTICS AND SENT HOME. ON (B)(6) 2016 - PATIENT CONTINUED WITH PAIN AND VISITS (B)(6) CLINIC. CLINIC SURGEON ALLEGES THAT THE PAIN IS DUE TO FOREIGN BODY COMPLICATION. ON (B)(6) 2016 - PATIENT HAD WORSENING PAIN AND ADMITTED TO HOSPITAL. CT SCAN WAS FINE. MRIS SHOWED EXTENSIVE EDEMA AROUND PROSTATE, PUBIC BONE, AND DISTAL RECTUM AT SITE OF PROSTATE. PATIENT WAS PRESCRIBED ANTIBIOTICS AND SENT HOME. NOV 22, 2016 - COMPLAINANT PHYSICIAN ALLEGES COLOSTOMY PROCEDURE OCCURRED SOMETIME BETWEEN (B)(6) 2016. AUGMENIX INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844256 SPACEOAR SYSTEM HYDROGEL SPACER OVB AUGMENIX, INC 01141502 00864661000010

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| O| R