BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN TOUCH SCRO ZERO ANG 22CM

    MDR report key: 7456470 · Received April 24, 2018

    Report

    Report Number
    2125050-2018-00305
    Event Type
    Injury
    Date Received
    April 24, 2018
    Date of Event
    March 26, 2018
    Report Date
    July 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP MDR IS CREATED TO DOCUMENT THE ADDITIONAL EVENT INFORMATION RECEIVED AND THE EVALUATION OF THE RETURNED DEVICE. A TITAN TOUCH PUMP WAS RECEIVED FOR EVALUATION. EXAMINATION AND TESTING OF THE RETURNED COMPONENT REVEALED NO FUNCTIONAL ABNORMALITIES WITH THE PUMP OR DETACHED CONNECTOR. THE INFORMATION RECEIVED INDICATED "A PUMP MALFUNCTION, FAULTY PUMP", BUT BECAUSE NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH THE RETURNED COMPONENTS, QUALITY CANNOT CONFIRM THE COMPLAINT AS REPORTED. 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 COMPLAINTS OF THE SAME FAILURE TYPE REPORTED FOR LOT 4203556. REVIEW OF NONCONFORMING REPORTS REVEALED NO NONCONFORMANCE'S WITH LOT 4203556 THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. NO CAPAS FOR ISSUES OF THIS TYPE ARE ASSOCIATED WITH LOT 4203556. 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.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, PUMP MALFUNCTION - FAULTY PUMP. ADDITIONAL INFORMATION RECEIVED INDICATED FAULTY PUMP. ON (B)(6), THE PHYSICIAN OPERATED ON THE PATIENT. THERE WAS NO FLUID TO CULTURE. HENCE, NO CULTURES WERE OBTAINED BUT WHEN THE PUMP WAS DELIVERED INTO THE WOUND, THE SPRING WAS NOT IN ITS CORRECT POSITION ALL CONTAINED IN THE DEVICE. THE PHYSICIAN TRIED TO UNTWIST THE DEVICE, PUMPED IT, AND REAPPLIED PRESSURE, AND EVEN WITH THE DEVICE FULLY IN THE PHYSICIANS HAND, HE WAS BARELY ABLE TO MAKE THE SPRING GO TO THE OTHER SIDE. THIS IS THE TOP SPRING THAT IS HORIZONTALLY SITUATED. THE PHYSICIAN FELT THAT THIS WAS THE ONGOING ISSUE FOR THE PATIENT'S PROBLEM, AND THEREFORE, CHANGED THE PUMP AFTER A MODIFIED MULCAHY WASHOUT. THE NEW PUMP FUNCTIONS VERY EASILY AND WAS WORKING EVEN WHEN IT WAS REPLACED BACK WITHIN THE SCROTUM.

    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, PUMP MALFUNCTION - FAULTY PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298183 TITAN TOUCH SCRO ZERO ANG 22CM INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S ES29222400 4203556 05708932539203

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other