BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN TOUCH SCRO ZERO ANG 20CM

    MDR report key: 8130694 · Received December 4, 2018

    Report

    Report Number
    2125050-2018-00863
    Event Type
    Injury
    Date Received
    December 4, 2018
    Date of Event
    October 16, 2018
    Report Date
    February 28, 2019
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    UDI-DI
    05708932539197
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP MDR IS CREATED TO DOCUMENT THE EVALUATION OF THE RETURNED DEVICE. A TITAN TOUCH PUMP, TWO CYLINDERS, AND A RESERVOIR WERE RECEIVED FOR EVALUATION. EXAMINATION AND TESTING OF THE RETURNED COMPONENTS REVEALED SURFACE ABRASION ON ALL TUBES OF THE PUMP, CYLINDER #1 AND CYLINDER #2. NO FUNCTIONAL ABNORMALITIES ARE NOTED WITH THE PUMP, CYLINDER #1, CYLINDER #2, OR THE RESERVOIR. THE INFORMATION RECEIVED INDICATED LOSS OF FLUID, 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 SIGNIFICANT TRENDS FOR LOT 6203704. REVIEW OF NONCONFORMING REPORTS REVEALED NO NONCONFORMANCE'S FOR THIS LOT. NO CAPAS ARE ASSOCIATED WITH THIS LOT.

    Additional Manufacturer Narrative · 1

    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, LOSS OF FLUID; PINHOLE PUNCTURE OBSERVED DURING EXPLANT UPON FILLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970717 TITAN TOUCH SCRO ZERO ANG 20CM INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S ES29202400 6203704 05708932539197

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other