BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TBD

    MDR report key: 6315669 · Received February 9, 2017

    Report

    Report Number
    3007966929-2017-00001
    Event Type
    Malfunction
    Date Received
    February 9, 2017
    Product Code
    FFG
    PMA / PMN Number
    UNK
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON NAME: DEVICE URINE FLOW RATE MEASURING, NON ELECTRICAL. BRAND NAME IS UNOMETER SAFETI. PRO CODE IS FFG. (B)(6). PMA/510K: EXEMPT. MANUFACTURING DATE: 11-2016. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A PRODUCT MALFUNCTION. NO PATIENT HARM WAS REPORTED. ADDITIONAL DETAILS HAVE BEEN REQUESTED BUT NOT PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    COMPLAINT REPORTED BY A NURSE THAT "A PATIENT HAD THE DEVICE PLACED FOR SURGERY AND URINE DID NOT DRAIN FROM THE BLADDER. WHEN THE OPERATION WAS OVER, THE BLADDER WAS SCANNED AND IT CONTAINED 650 ML OF URINE. THE URINE WAS EASY TO ASPIRATE OUT FROM THE CATHETER, BUT IT DID NOT DRAIN INTO THE COLLECTION BAG. THE NON RETURN VALVE DID NOT WORK." THE PRODUCT WAS REMOVED AND REPLACED WITH ANOTHER SIMILAR CONVATEC DEVICE THAT WORKED WITH NO ISSUE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96244 TBD FFG 509042 305264

    Patients

    Seq Age Sex Outcome Treatment
    1