BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN TOUCH

    MDR report key: 12160546 · Received July 13, 2021

    Report

    Report Number
    2125050-2021-00893
    Event Type
    Injury
    Date Received
    July 13, 2021
    Report Date
    January 6, 2022
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    UDI-DI
    05708932539203
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE AVAILABLE INFORMATION THIS INFLATABLE DEVICE WAS TO BE REMOVED/REPLACED ON (B)(6) 2021. THE IMPLANT WAS FUNCTIONING WELL BUT WAS BEGINNING TO ERODE DISTALLY ON THE RIGHT SIDE. SURGEON WANTED DISTAL SOCK ADDED. EXAMINATION OF THE RETURNED COMPONENTS REVEALED NO ABNORMALITIES THAT WOULD HAVE CONTRIBUTED TO THE REPORT OF EROSION. HOWEVER, BECAUSE EXAMINATION OF THE RETURNED COMPONENTS MAY NOT CONCLUSIVELY CONFIRM OR DISPROVE THE REPORT OF EROSION, QUALITY ACCEPTS THE PHYSICIAN¿S OBSERVATIONS OF SUCH AS THE REASON FOR SURGICAL INTERVENTION. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE DEVICES FROM THIS LOT MET ALL SPECIFICATIONS PRIOR TO RELEASE. A REVIEW OF THE COMPLAINT HISTORY DATABASE, NONCONFORMANCES AND CAPAS REVEALED NO TRENDS FOR THIS LOT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL REVIEW DETERMINED THIS EVENT WAS ALSO REPORTED UNDER MANUFACTURER REPORT NUMBER 2125050-2021-01418; DUPLICATE COMPLAINTS HAVE SINCE BEEN MERGED AND ANY FURTHER INFORMATION RECEIVED REGARDING THIS EVENT WILL BE SUBMITTED UNDER MANUFACTURER REPORT NUMBER 2125050-2021-01418. H6 CODE A040503 "MATERIAL EROSION" HAS BEEN CORRECTED TO A24 "ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM". H6 CODE F24 "INSUFFICIENT INFORMATION" HAS BEEN CORRECTED TO F1905 "DEVICE REVISION OR REPLACEMENT".

    Description of Event or Problem · 0

    BASED ON THE AVAILABLE INFORMATION, THE REPORTED COMPLAINT IS IDENTIFIED IN THE RISK MANAGEMENT DOCUMENTATION AND REVIEWED ROUTINELY WITH MANAGEMENT TO MONITOR COMPLAINT TRENDS AS PART OF POST MARKET SURVEILLANCE. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    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. SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE LOT # WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. DEVICES MET SPECIFICATION PRIOR TO RELEASE AND NO TRENDS WERE NOTED.

    Description of Event or Problem · 1

    ACCORDING TO AVAILABLE INFORMATION, THE DEVICE WAS BEGINNING TO ERODE DISTALLY. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053009 TITAN TOUCH INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S ES29222400 7150039 05708932539203

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention