BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN TOUCH SCRO ZERO ANG 16CM

    MDR report key: 7487726 · Received May 4, 2018

    Report

    Report Number
    2125050-2018-00343
    Event Type
    Injury
    Date Received
    May 4, 2018
    Date of Event
    April 10, 2018
    Report Date
    June 15, 2018
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    UDI-DI
    05708932539173
    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, TWO CYLINDERS AND A RESERVOIR WERE RECEIVED FOR EVALUATION. EXAMINATION AND TESTING OF THE RETURNED COMPONENTS REVEALED A ROUGH AND IRREGULAR SEPARATION IN THE TUBING NEAR THE STRAIN RELIEF OF CYLINDER 2. TESTING REVEALED THIS TO BE A SITE OF LEAKAGE. SURFACE ABRASION WAS NOTED ON THE STRAIN RELIEF AND INLET TUBE OF THE PUMP AND PUMP EXHAUST TUBE GOING TO CYLINDER 2. NO VISUAL OR FUNCTIONAL ABNORMALITIES WERE NOTED WITH THE PUMP, RESERVOIR OR CYLINDER 1. BASED ON PREVIOUS QUALITY SIMULATIONS AND EXAMINATION OF THE RETURNED PRODUCT, QUALITY CONCLUDED THAT THE ROUGH AND IRREGULAR SURFACES ASSOCIATED WITH THIS SEPARATION INDICATES THAT SUFFICIENT STRESS(S) WAS EXERTED ON THE EXHAUST TUBING TO CYLINDER 2 TO SEPARATE THE SITE WHILE IN-VIVO. 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. 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 3893913. 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, NOT INFLATING - TUBING BREAK AT CYLINDER INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328790 TITAN TOUCH SCRO ZERO ANG 16CM INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S ES29162400 3893913 05708932539173

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other