BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN OTR NAR SCRO 16CM

    MDR report key: 7850252 · Received September 6, 2018

    Report

    Report Number
    2125050-2018-00651
    Event Type
    Injury
    Date Received
    September 6, 2018
    Date of Event
    August 2, 2018
    Report Date
    September 21, 2018
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP MDR IS CREATED TO DOCUMENT THE EVALUATION OF THE RETURNED DEVICE. A TITAN OTR PUMP AND TWO CYLINDERS WERE RECEIVED FOR EVALUATION. EXAMINATION AND TESTING OF THE RETURNED COMPONENTS REVEALED SURFACE ABRASION ON THE PUMP EXHAUST TUBE GOING TO CYLINDER 1 AND ON THE PUMP INLET TUBE. TOW SUTURES WITH INTACT PLASTIC SHEATHES WERE PRESENT ON CYLINDERS 1 AND 2, INDICATING THE DEVICES HAD NOT BEEN IMPLANTED. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH THE PUMP. NO VISUAL OR FUNCTIONAL ABNORMALITIES WERE NOTED WITH CYLINDERS 1 AND 2. THE INFORMATION RECEIVED INDICATED TUBING LEAKAGE. HOWEVER, BECAUSE THE DETACHMENT SITES OF THE RETURNED COMPONENTS WERE SMOOTH AND STRIATED INDICATING CONTACT WITH SHARP INSTRUMENTATION, AND BECAUSE NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH THE RETURNED COMPONENTS, QUALITY WAS UNABLE TO CONFIRM THE REPORT OF TUBING LEAKAGE BASED ON EXAMINATION OF THE RETURNED COMPONENTS. 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 5073510. 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, TUBING LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694365 TITAN OTR NAR SCRO 16CM INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S QNR9161022 5073510

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other