BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN TOUCH NB SCROT ZERO 14CM

    MDR report key: 8080835 · Received November 16, 2018

    Report

    Report Number
    2125050-2018-00819
    Event Type
    Injury
    Date Received
    November 16, 2018
    Date of Event
    October 15, 2018
    Report Date
    June 21, 2019
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP MDR IS CREATED TO DOCUMENT THE CONCLUSION OF THE INVESTIGATION. QUALITY WAS UNSUCCESSFUL IN SECURING THE DEVICE FOR EVALUATION. WITHOUT THE BENEFIT OF ANALYZING THE DEVICE, QUALITY CANNOT CONFIRM ANY OBSERVATIONS AND CANNOT COMMENT ON THE CONDITION OF THE DEVICE. IF THE DEVICE BECOMES AVAILABLE, OR ADDITIONAL INFORMATION IS RECEIVED, QUALITY WILL RE-EVALUATE THIS COMPLAINT IN ACCORDANCE TO PROCEDURES. 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 5120928. REVIEW OF NONCONFORMING REPORTS REVEALED NO NONCONFORMANCE'S FOR THIS LOT. NO CAPAS ARE ASSOCIATED WITH THIS LOT.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP MDR IS CREATED TO DOCUMENT THE EVALUATION OF THE RETURNED DEVICE. A TITAN TOUCH AND TWO CYLINDERS WERE RECEIVED FOR EVALUATION. EXAMINATION AND TESTING OF THE RETURNED COMPONENTS REVEALED A SEPARATION IN THE EXHAUST TUBE OF CYLINDER 1 NEAR THE BASE. TESTING REVEALED THIS TO BE A SITE OF LEAKAGE. MICROSCOPIC EXAMINATION REVEALED A SMALL AREA OF ABRASION ADJACENT TO THIS SEPARATION, INDICATING THE TUBE HAD KINKED ONTO ITSELF. ABRASION WAS NOTED ON ALL PUMP TUBES. TOW SUTURES WERE ATTACHED TO CYLINDER 2. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH THE PUMP OR CYLINDER 2. BASED ON EXAMINATION OF THE RETURNED PRODUCT, THE ABRASION MARKS NOTED ON ALL PUMP TUBING MATCHED IN SUCH A WAY TO CONCLUDE THAT THEY HAD OVERLAPPED AND ABRADED AGAINST ONE ANOTHER WHILE IN-VIVO. THIS THEN MOST LIKELY CAUSED THE EXHAUST TUBE OF CYLINDER 1 TO BE KINKED ONTO ITSELF AND ABRADE FOR A PERIOD OF TIME. THE ABRASION THEN RESULTED IN THE SEPARATION NOTED IN THE TUBING. A SEPARATION OF THIS TYPE WOULD THEN ALLOW THE LOSS OF FLUID, MAKING THE DEVICE INOPERABLE. 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 5120928. 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, CYLINDER LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918432 TITAN TOUCH NB SCROT ZERO 14CM INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S EN29141022 5120928

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other