BEUDAMED
    FDA Adverse Event Injury Summary report: N

    (2BO)TITAN OTR INFRA ZERO ANG

    MDR report key: 8773191 · Received July 9, 2019

    Report

    Report Number
    2125050-2019-00557
    Event Type
    Injury
    Date Received
    July 9, 2019
    Date of Event
    April 4, 2019
    Report Date
    October 16, 2019
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    UDI-DI
    05708932487580
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP MDR IS CREATED TO DOCUMENT THE EVALUATION OF THE RETURNED DEVICE. TITAN OTR PUMP, TWO CYLINDERS AND DETACHED INLET TUBE WITH CONNECTOR WERE RECEIVED FOR EVALUATION. EXAMINATION AND TESTING OF THE RETURNED COMPONENTS REVEALED PARTIAL SEPARATION WITHIN ABRASION ON THE EXHAUST TUBE OF CYLINDER 2. TESTING REVEALED THESE TO NOT BE SITES OF LEAKAGE. ABRASION WAS NOTED ON ALL TUBES OF THE PUMP AND DETACHED INLET TUBE WITH CONNECTOR. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH ANY OF THE RETURNED COMPONENTS. BECAUSE THE AVAILABLE INFORMATION DID NOT INDICATE WHAT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED MALFUNCTION, AND BECAUSE NO FUNCTIONAL ABNORMALITIES WERE NOTED, QUALITY CANNOT DETERMINE THE CAUSE OF THIS REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE DEVICES FROM THIS LOT MET ALL SPECIFICATIONS PRIOR TO RELEASE. A REVIEW OF THE COMPLAINT HISTORY DATABASE, NONCONFORMANCE'S AND CAPAS REVEALED NO TRENDS FOR THIS LOT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AT COLOPLAST; HOWEVER THE EVALUATION IS NOT YET COMPLETE. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. ONCE OUR EVALUATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ACCORDING TO THE AVAILABLE INFORMATION, MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565883 (2BO)TITAN OTR INFRA ZERO ANG INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S ESR8222400 3902940 05708932487580

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other