BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN TOUCH SCRO ZERO ANG 18CM

    MDR report key: 7516019 · Received May 15, 2018

    Report

    Report Number
    2125050-2018-00368
    Event Type
    Injury
    Date Received
    May 15, 2018
    Date of Event
    April 23, 2018
    Report Date
    June 15, 2018
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    UDI-DI
    05708932539180
    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, RESERVOIR, AND TWO CYLINDERS WERE RECEIVED FOR EVALUATION. A SMALL SEPARATION WITH A MELTED APPEARANCE WAS NOTED IN THE BLADDER OF CYLINDER 1 NEAR THE BASE. TESTING REVEALED THIS TO BE A SITE OF LEAKAGE. SURFACE ABRASION WAS NOTED ON ALL TUBES OF THE PUMP AND CYLINDERS. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH CYLINDER 2, THE PUMP, OR THE RESERVOIR. 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. REVIEW OF NONCONFORMING REPORTS REVEALED NO NONCONFORMANCE WITH THIS LOT THAT WOULD HAVE CONTRIBUTED TO THE EVENT. A REVIEW OF THE COMPLAINT DATABASE REVEALED NO SIGNIFICANT TRENDS IN COMPLAINTS OF THIS TYPE FOR LOT 5022043. BECAUSE THESE COMPONENTS WERE RELEASED ACCORDING TO MANUFACTURING AND QUALITY CONTROL PROCEDURES, QUALITY CONCLUDED THAT THE OBSERVED INSTRUMENT SEPARATION IN THE BLADDER OF CYLINDER 1 OCCURRED SUBSEQUENT TO THE DEVICE PACKAGING BEING OPENED. IN ADDITION, BECAUSE SURFACES APPEAR MELTED INDICATING CONTACT WITH CAUTERIZING INSTRUMENTATION, AND THE EXPECTED USE OF THIS DEVICE COMBINED WITH THE OBSERVED SEPARATION WOULD HAVE RESULTED IN AN EARLIER DETECTED FLUID LOSS, QUALITY CONCLUDED THAT THE SEPARATION MOST LIKELY OCCURRED DURING OR AFTER EXPLANT. THIS SEPARATION IS NOT ASSOCIATED WITH THE CAUSE FOR FAILURE. THE INFORMATION RECEIVED INDICATED A TUBING ISSUE, BUT BECAUSE NO FUNCTIONAL ABNORMALITIES WERE NOTED OTHER THAN INSTRUMENT DAMAGE, QUALITY IS UNABLE TO CONFIRM THE REPORTED COMPLAINT. 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.

    Description of Event or Problem · 1

    ACCORDING TO THE AVAILABLE INFORMATION, TITAN TOUCH WAS EXPLANTED DUE TO A TUBING ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356423 TITAN TOUCH SCRO ZERO ANG 18CM INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S ES29182400 5022043 05708932539180

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other