BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN TOUCH PUMP

    MDR report key: 7516021 · Received May 15, 2018

    Report

    Report Number
    2125050-2018-00369
    Event Type
    Injury
    Date Received
    May 15, 2018
    Date of Event
    April 24, 2018
    Report Date
    June 18, 2018
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    UDI-DI
    05708932533966
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP MDR IS CREATED TO DOCUMENT THE EVALUATION OF THE RETURNED DEVICE. A TITAN TOUCH PUMP WAS RECEIVED FOR EVALUATION. EXAMINATION AND TESTING OF THE RETURNED COMPONENT REVEALED NO FUNCTIONAL ABNORMALITIES WITH THE PUMP. THE INFORMATION RECEIVED INDICATED A HARD PUMP, BUT BECAUSE NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH THE RETURNED COMPONENTS, QUALITY CANNOT CONFIRM THE COMPLAINT AS REPORTED. QUALITY REVIEWED THE MANUFACTURING RECORDS FOR THIS DEVICE AND CONFIRMED THAT THERE WERE NO DISCREPANCIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT AND VERIFIED THAT THE DEVICES FROM THIS LOT MET ALL SPECIFICATIONS PRIOR TO RELEASE. A REVIEW OF THE COMPLAINT HISTORY DATABASE REVEALED NO ADDITIONAL COMPLAINTS FOR LOT 5813255. REVIEW OF NONCONFORMING REPORTS REVEALED NO NONCONFORMANCE'S FOR THIS LOT. NO CAPAS ARE ASSOCIATED WITH THIS LOT. MANAGEMENT ROUTINELY REVIEWS EVENTS SUCH AS THIS AND MONITORS COMPLAINT LEVELS. ADDITIONALLY, EVENTS OF THIS TYPE ARE CAPTURED IN THE PRODUCT RISK DOCUMENTATION. BASED ON THIS INFORMATION, NO FURTHER CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    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. QUALITY REVIEWED THE MANUFACTURING RECORDS FOR THIS DEVICE AND CONFIRMED THAT THERE WERE NO DISCREPANCIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT AND VERIFIED THAT THE DEVICES FROM THIS LOT MET ALL SPECIFICATIONS PRIOR TO RELEASE.

    Description of Event or Problem · 1

    ACCORDING TO THE AVAILABLE INFORMATION, PUMP NOT CYCLING. DESCRIBED AS BULB WILL NOT DEPRESS, PUMP GETS STUCK. DOCTOR INDICATED THAT SHE HAD TO REALLY WORK THE PUMP TO GET IT GOING. THE DEVICE WAS EXPLANTED ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356425 TITAN TOUCH PUMP INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S 5177502400 5813255 05708932533966

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other