BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN TOUCH

    MDR report key: 11882088 · Received May 25, 2021

    Report

    Report Number
    2125050-2021-00632
    Event Type
    Injury
    Date Received
    May 25, 2021
    Date of Event
    April 12, 2021
    Report Date
    September 15, 2021
    Manufacturer
    COLOPLAST A/S
    Product Code
    JCW
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON EXAMINATION OF THE RETURNED PRODUCT, IT WAS CONCLUDED THAT THE ABRASION MARKS NOTED ON THE SHORTER PUMP EXHAUST STRAIN RELIEF, PUMP INLET STRAIN RELIEF, AND ALL PUMP TUBING INDICATED THEY MAY HAVE OVERLAPPED AND ABRADED AGAINST ONE ANOTHER WHILE IN-VIVO. THIS POSITIONING, IN COMBINATION WITH DEVICE USAGE OVER TIME, MAY HAVE CONTRIBUTED TO THE PUMP EXHAUST TUBING/CONNECTOR SEGMENT KINKING ONTO ITSELF AND ABRADING, RESULTING IN SUFFICIENT STRESS(S) TO CAUSE A SEPARATION OF THE PUMP EXHAUST TUBING/CONNECTOR SEGMENT. A SEPARATION OF THIS TYPE MAY THEN ALLOW THE LOSS OF FLUID, RENDERING THE DEVICE INOPERABLE.

    Additional Manufacturer Narrative · 1

    THE LOT # WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. DEVICES MET SPECIFICATION PRIOR TO RELEASE AND NO TRENDS WERE NOTED. 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.

    Description of Event or Problem · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS EXPLANTED AND REPLACED DUE TO A PUMP TUBING LEAKAGE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770869 TITAN TOUCH INFLATABLE PENILE PROSTHESIS JCW COLOPLAST A/S ES29181022 6516961

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R