BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN TOUCH SCRO ZERO ANG 22CM

    MDR report key: 7535189 · Received May 22, 2018

    Report

    Report Number
    2125050-2018-00401
    Event Type
    Injury
    Date Received
    May 22, 2018
    Date of Event
    April 30, 2018
    Report Date
    May 22, 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 · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE BENEFIT OF ANALYZING THE EXPLANT, QUALITY CANNOT CONFIRM ANY OBSERVATIONS AND CANNOT COMMENT ON THE CONDITION OF THE PROSTHESIS. 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 ADDITIONAL REPORTS OR TRENDS OF INCORRECT SIZING ASSOCIATED WITH LOT NUMBER 4904043. REVIEW OF NONCONFORMANCES REVEALED NO NONCONFORMANCE WITH THIS LOT THAT WOULD HAVE CONTRIBUTED TO THE EVENT. THE MOST LIKELY ROOT CAUSE OF THE EVENT MAY BE ATTRIBUTED TO INCORRECT SIZING OF THE PATIENT DURING THE IMPLANT PROCEDURE. IF ADDITIONAL INFORMATION IS RECEIVED, QUALITY WILL RE-EVALUATE THIS COMPLAINT IN ACCORDANCE TO 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.

    Description of Event or Problem · 1

    ACCORDING TO THE AVAILABLE INFORMATION, THE PHYSICIAN SHORTENED THE TUBING LENGTH AND DID A WASHOUT. REPOSITIONED THE SAME PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374774 TITAN TOUCH SCRO ZERO ANG 22CM INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S ES29222400 4904043 05708932539203

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other