BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEOAR VUE? SYSTEM - 10ML

    MDR report key: 22288067 · Received June 18, 2025

    Report

    Report Number
    2124215-2025-37863
    Event Type
    Injury
    Date Received
    June 18, 2025
    Date of Event
    May 19, 2025
    Report Date
    August 28, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OVB
    UDI-DI
    00864661000140
    PMA / PMN Number
    K182971
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETED UDI AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK D4:H4 THE EVENT WAS UNABLE TO PROVIDE THE LOT NUMBER OF THE DEVICE IMPLANTED. THEREFORE, THERE IS NOT INFORMATION RELATED WITH DEVICE MANUFACTURER DAY. BLOCK H6: IMDRF PATIENT CODE E2330 CAPTURES THE REPORTABLE EVENT OF PAIN. IMDRF PATIENT CODE E171601 CAPTURES THE REPORTABLE EVENT OF ERYTHEMA. IMDRF PATIENT CODE E1708 CAPTURES THE REPORTABLE EVENT OF ITCHING. IMDRF PATIENT CODE E2311 CAPTURES THE REPORTABLE EVENT OF DISCOMFORT. IMDRF PATIENT CODE E0402 CAPTURES THE REPORTABLE EVENT OF ALLERGIC REACTION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: BLOCK B5 HAS BEEN UPDATED WITH THE ADDITIONAL INFORMATION. ADDITIONAL INFORMATION: BLOCK B5 AND D4 HAVE BEEN UPDATED WITH THE INFORMATION PROVIDED. BLOCK H6: IMDRF PATIENT CODE E2330 CAPTURES THE REPORTABLE EVENT OF PAIN. IMDRF PATIENT CODE E171601 CAPTURES THE REPORTABLE EVENT OF ERYTHEMA. IMDRF PATIENT CODE E1708 CAPTURES THE REPORTABLE EVENT OF ITCHING. IMDRF PATIENT CODE E2311 CAPTURES THE REPORTABLE EVENT OF DISCOMFORT. IMDRF PATIENT CODE E0402 CAPTURES THE REPORTABLE EVENT OF ALLERGIC REACTION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION BLOCK B5 AND D4 HAVE BEEN UPDATED WITH THE INFORMATION PROVIDED. BLOCK H6: IMDRF PATIENT CODE E2330 CAPTURES THE REPORTABLE EVENT OF PAIN. IMDRF PATIENT CODE E171601 CAPTURES THE REPORTABLE EVENT OF ERYTHEMA. IMDRF PATIENT CODE E1708 CAPTURES THE REPORTABLE EVENT OF ITCHING. IMDRF PATIENT CODE E2311 CAPTURES THE REPORTABLE EVENT OF DISCOMFORT. IMDRF PATIENT CODE E0402 CAPTURES THE REPORTABLE EVENT OF ALLERGIC REACTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING THE SPACEOAR PLACEMENT PROCEDURE, THE PATIENT EXPERIENCED REDNESS/ITCHINESS IN HIS GROIN. THE PATIENT WENT TO URGENT CARE AND RECEIVED BENADRYL AND STEROIDS, THE SYMPTOMS PERSISTED AND SPREAD BEYOND THE GROIN TO BUTTOCKS, BACK AND LEGS RESULTING IN CONTINUE URGENT CARE VISITS. THE PATIENT ALSO REPORTED THAT HE FEELS PAIN, DISCOMFORT AND UNDESIRED SENSATIONS. THE PATIENT HAS BEEN DISCHARGED FROM HOSPITAL, BUT THE ISSUE WAS REPORTED AS ONGOING. THE PHYSICIAN INDICATED THAT THE PATIENT IS HAVING A PERSISTENT ALLERGIC REACTION TO THE POLYETHYLENE GLYCOL (PEG), THEREFORE, IS LOOKING FOR POTENTIAL SOLUTIONS FOR THE PATIENT UNTIL THE DEVICE DISSOLVED. DESPITE BSC'S EFFORTS, NO FURTHER PATIENT HEALTH INFORMATION, UNDERLYING HEALTH CONCERNS, DETAILS ON THE EVENT AND THE PATIENT'S COURSE AFTER THE EVENT, OR DETAILS REGARDING POST PROCEDURE MONITORING AND OBSERVATION HAVE BEEN RECEIVED TO DATE. IF BSC RECEIVES ADDITIONAL PERTINENT INFORMATION, IT WILL BE PROVIDED TO THE FDA A SUPPLEMENTAL MEDICAL DEVICE REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING THE SPACEOAR PLACEMENT PROCEDURE, THE PATIENT EXPERIENCED REDNESS/ITCHINESS IN HIS GROIN. THE PATIENT WENT TO URGENT CARE AND RECEIVED BENADRYL AND STEROIDS, THE SYMPTOMS PERSISTED AND SPREAD BEYOND THE GROIN TO BUTTOCKS, BACK AND LEGS RESULTING IN CONTINUE URGENT CARE VISITS. THE PATIENT ALSO REPORTED THAT HE FEELS PAIN, DISCOMFORT AND UNDESIRED SENSATIONS. THE PATIENT HAS BEEN DISCHARGED FROM HOSPITAL, BUT THE ISSUE WAS REPORTED AS ONGOING. THE PHYSICIAN INDICATED THAT THE PATIENT IS HAVING A PERSISTENT ALLERGIC REACTION TO THE POLYETHYLENE GLYCOL (PEG), THEREFORE, IS LOOKING FOR POTENTIAL SOLUTIONS FOR THE PATIENT UNTIL THE DEVICE DISSOLVED. DESPITE BSC'S EFFORTS, NO FURTHER PATIENT HEALTH INFORMATION, UNDERLYING HEALTH CONCERNS, DETAILS ON THE EVENT AND THE PATIENT'S COURSE AFTER THE EVENT, OR DETAILS REGARDING POST PROCEDURE MONITORING AND OBSERVATION HAVE BEEN RECEIVED TO DATE. IF BSC RECEIVES ADDITIONAL PERTINENT INFORMATION, IT WILL BE PROVIDED TO THE FDA A SUPPLEMENTAL MEDICAL DEVICE REPORT. ADDITIONAL INFORMATION: IT WAS FURTHER REPORTED THAT THE PHYSICIAN REVIEWED THE CHART WITH THE PATIENT'S ALLERGIC HISTORY, THE ONLY WAS ALLERGY WAS PENICILLIN (PCN) AND AS A CHILD AND CEPHALOSPORINS. AFTER THE PROCEDURE, THE PATIENT WAS PRESCRIBED WITH PREDNISONE, THE PATIENT IS CURRENTLY IN TREATMENT, DOING WELL FROM ALLERGIC REACTION STANDPOINT. ADDITIONAL INFORMATION: IT WAS FURTHER REPORTED THAT THE PHYSICIAN REQUESTED A SECOND OPINION WITH THE DERMATOLOGIST OF THE PATIENT TO REQUEST AN ALLERGIC TEST TO DISCARD ANY PEG SENSITIVE REACTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING THE SPACEOAR PLACEMENT PROCEDURE, THE PATIENT EXPERIENCED REDNESS/ITCHINESS IN HIS GROIN. THE PATIENT WENT TO URGENT CARE AND RECEIVED BENADRYL AND STEROIDS, THE SYMPTOMS PERSISTED AND SPREAD BEYOND THE GROIN TO BUTTOCKS, BACK AND LEGS RESULTING IN CONTINUE URGENT CARE VISITS. THE PATIENT ALSO REPORTED THAT HE FEELS PAIN, DISCOMFORT AND UNDESIRED SENSATIONS. THE PATIENT HAS BEEN DISCHARGED FROM HOSPITAL, BUT THE ISSUE WAS REPORTED AS ONGOING. THE PHYSICIAN INDICATED THAT THE PATIENT IS HAVING A PERSISTENT ALLERGIC REACTION TO THE POLYETHYLENE GLYCOL (PEG), THEREFORE, IS LOOKING FOR POTENTIAL SOLUTIONS FOR THE PATIENT UNTIL THE DEVICE DISSOLVED. DESPITE BSC'S EFFORTS, NO FURTHER PATIENT HEALTH INFORMATION, UNDERLYING HEALTH CONCERNS, DETAILS ON THE EVENT AND THE PATIENT'S COURSE AFTER THE EVENT, OR DETAILS REGARDING POST PROCEDURE MONITORING AND OBSERVATION HAVE BEEN RECEIVED TO DATE. IF BSC RECEIVES ADDITIONAL PERTINENT INFORMATION, IT WILL BE PROVIDED TO THE FDA A SUPPLEMENTAL MEDICAL DEVICE REPORT. ADDITIONAL INFORMATION IT WAS FURTHER REPORTED THAT THE PHYSICIAN REVIEWED THE CHART WITH THE PATIENT'S ALLERGIC HISTORY, THE ONLY WAS ALLERGY WAS PENICILLIN (PCN) AND AS A CHILD AND CEPHALOSPORINS. AFTER THE PROCEDURE, THE PATIENT WAS PRESCRIBED WITH PREDNISONE, THE PATIENT IS CURRENTLY IN TREATMENT, DOING WELL FROM ALLERGIC REACTION STANDPOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1684919 SPACEOAR VUE? SYSTEM - 10ML ABSORBABLE PERIRECTAL SPACER OVB BOSTON SCIENTIFIC CORPORATION SV-2101 0036176546 00864661000140

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R