BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 800 URINARY CONTROL SYSTEM

    MDR report key: 8995197 · Received September 11, 2019

    Report

    Report Number
    2183959-2019-66140
    Event Type
    Injury
    Date Received
    September 11, 2019
    Date of Event
    September 2, 2019
    Report Date
    September 30, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZY
    UDI-DI
    00878953005461
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED THAT THE DEVICE HAD A LEAK IN IT. THE PATIENT OUTCOME WAS REPORTED TO BE WELL. SYSTEM COMPONENTS: PUMP, MODEL- 72400098, LOT SN- (B)(4), MFG DATE- 08/22/2018, EXP DATE- 08/21/2023, GTIN- 00878953000688. BALLOON, MODEL- 72400024, LOT SN- (B)(4), MFG DATE- 09/24/2018, EXP DATE- 09/23/2023, GTIN- 00878953000626.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SALINE SUPPLEMENTATION TO THE EXISTING ARTIFICIAL URINARY SPHINCTER(AUS) BALLOON. THE DEVICE WAS NOT REMOVED. A PATIENT OUTCOME WAS NOT REPORTED.

    Additional Manufacturer Narrative · 1

    SYSTEM COMPONENTS: PUMP: MODEL- 72400098, LOT SN- (B)(4), MFG DATE- 08/22/2018, EXP DATE- 08/21/2023, GTIN- (B)(4). BALLOON: MODEL- 72400024, LOT SN- (B)(4), MFG DATE- 09/24/2018, EXP DATE- 09/23/2023, GTIN- (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SALINE SUPPLEMENTATION TO THE EXISTING ARTIFICIAL URINARY SPHINCTER(AUS) BALLOON. THE DEVICE WAS NOT REMOVED. A PATIENT OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793091 AMS 800 URINARY CONTROL SYSTEM DEVICE INCONTINENCE MECHANICAL/HYDRAULIC EZY BOSTON SCIENTIFIC CORPORATION 720133-01 1000041560 00878953005461

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| O