BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN TOUCH SCRO ZERO ANG 22CM

    MDR report key: 7567212 · Received June 4, 2018

    Report

    Report Number
    2125050-2018-00432
    Event Type
    Injury
    Date Received
    June 4, 2018
    Date of Event
    May 8, 2018
    Report Date
    October 10, 2018
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    UDI-DI
    05708932539203
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    REQUESTS FOR THE DEVICE AND FOR ADDITIONAL INFORMATION SURROUNDING THIS EVENT HAVE BEEN MADE. HOWEVER, TO DATE NEITHER THE DEVICE NOR THE INFORMATION HAS BEEN RECEIVED. WITHOUT THE BENEFIT OF ANALYZING THE DEVICE AND WITHOUT THE REQUESTED INFORMATION, QUALITY CANNOT COMMENT ON THE CONDITION OF THE DEVICE OR THE EVENTS SURROUNDING THIS INCIDENT. 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 4203557. THE MOST LIKELY ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED AT THIS TIME. IF THE EXPLANTED DEVICE OR ADDITIONAL INFORMATION IS RECEIVED, QUALITY WILL RE-EVALUATE THIS EVENT IN ACCORDANCE WITH PROCEDURES. 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 · 0

    A TITAN TOUCH PUMP, TWO CYLINDERS AND DETACHED EXHAUST TUBING WERE RECEIVED FOR EVALUATION. EXAMINATION AND TESTING OF THE RETURNED COMPONENTS REVEALED A SEPARATION WITHIN ABRASION IN THE SHORTER EXHAUST TUBE OF THE PUMP NEAR THE STRAIN RELIEF. TESTING REVEALED THIS TO BE A SITE OF LEAKAGE. THE SEPARATION APPEARED ROUGH AND IRREGULAR, INDICATING SUFFICIENT STRESS(S) WAS EXERTED TO SEPARATE THE SITE. PARTIAL SEPARATIONS WITHIN ABRASION WERE NOTED IN THE LONGER EXHAUST TUBE AND THE INLET TUBE OF THE PUMP. TESTING REVEALED THESE NOT TO BE SITES OF LEAKAGE. SURFACE ABRASION WAS NOTED ON THE STRAIN RELIEF OF THE LONGER EXHAUST TUBE OF THE PUMP, THE STRAIN RELIEF OF THE INLET TUBE OF THE PUMP, ON THE LONGER EXHAUST TUBE OF THE PUMP, AND ON THE STRAIN RELIEF AND EXHAUST TUBES OF CYLINDERS 1 AND 2. SURFACE ABRASION WAS NOTED IN THE DETACHED EXHAUST TUBING NEAR THE DETACHMENT SITE. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH THE CYLINDERS. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH THE DETACHED TUBING. BASED ON QUALITY'S EXAMINATION, QUALITY CONCLUDED THAT WHILE IN-VIVO THE EXHAUST TUBES AND INLET TUBE POSITIONED THEMSELVES IN SUCH A WAY THAT CAUSED THEM TO OVERLAP AND ABRADE AGAINST ONE ANOTHER. QUALITY FURTHER CONCLUDED THAT THIS POSITIONING, IN COMBINATION WITH DEVICE USAGE OVER TIME, COULD CONTRIBUTE TO SUFFICIENT STRESS(S) TO SEPARATE THE SHORTER EXHAUST TUBE OF THE PUMP. A SEPARATION OF THIS TYPE WOULD THEN ALLOW THE LOSS OF FLUID, MAKING THE DEVICE INOPERABLE.

    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, TUBING BREAK BY PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408965 TITAN TOUCH SCRO ZERO ANG 22CM INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S ES29222400 4203557 05708932539203

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other