BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE FURLOW TOOL

    MDR report key: 19701415 · Received July 9, 2024

    Report

    Report Number
    2124215-2024-41924
    Event Type
    Injury
    Date Received
    July 9, 2024
    Date of Event
    May 20, 2024
    Report Date
    May 23, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QGA
    UDI-DI
    00878953000992
    PMA / PMN Number
    N970012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED TO UPDATE B5 DESCRIBE EVENT/PROBLEM. 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 COMPLETE UDI AND OTHER SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION TO D1 BRAND NAME, D2A COMMON DEVICE NAME, D2B PRO CODE (PRODUCT CODE), D4 MODEL NUMBER, D4 CATALOG NUMBER, D4 UNIQUE IDENTIFIER, D6A IMPLANT DATE, D5 OPERATOR OF DEVICE, H6 IMPACT CODES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT ENROLLED IN THE IT MATTERS STUDY AND WAS IMPLANTED WITH THIS AMBICOR PENILE PROSTHESIS (APP) ON (B)(6) 2024. TWENTY SIX DAYS POST IMPLANT, THE PATIENT PRESENTED WITH HEMATOMA IN FRONT OF THE PUMP. THE PHYSICIAN SUSPECTED THAT THE HEMATOMA WAS A RESULT OF THE FURLOW INSERTION TOOL. THERE HAS BEEN NO SURGICAL INTERVENTION AND NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT ENROLLED IN THE IT MATTERS STUDY AND WAS IMPLANTED WITH THIS AMBICOR PENILE PROSTHESIS (APP) ON (B)(6) 2024. TWENTY-SIX DAYS POST IMPLANT, THE PATIENT PRESENTED WITH HEMATOMA IN FRONT OF THE PUMP. THE PHYSICIAN SUSPECTED THAT THE HEMATOMA WAS A RESULT OF THE FURLOW INSERTION TOOL. THERE HAS BEEN NO SURGICAL INTERVENTION AND NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED. THE HEMATOMA WAS RESOLVED ON (B)(6) 2024.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT ENROLLED IN THE IT MATTERS STUDY AND WAS IMPLANTED WITH THIS AMBICOR PENILE PROSTHESIS (APP) ON (B)(6) 2024. TWENTY SIX DAYS POST IMPLANT, THE PATIENT PRESENTED WITH HEMATOMA IN FRONT OF THE PUMP. THE PHYSICIAN SUSPECTED THAT THE HEMATOMA WAS A RESULT OF THE FURLOW INSERTION TOOL. THERE HAS BEEN NO SURGICAL INTERVENTION AND NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1269310 DISPOSABLE FURLOW TOOL PENILE IMPLANT SURGICAL ACCESSORIES QGA BOSTON SCIENTIFIC CORPORATION UNK-P-DISPOSABLE_FURLOW_TOOL 00878953000992
    592662 DISPOSABLE FURLOW TOOL PENILE IMPLANT SURGICAL ACCESSORIES QGA BOSTON SCIENTIFIC CORPORATION UNK-P-DISPOSABLE_FURLOW_TOOL 00878953000992

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Other