BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN TOUCH

    MDR report key: 14408613 · Received May 16, 2022

    Report

    Report Number
    2125050-2022-00518
    Event Type
    Injury
    Date Received
    May 16, 2022
    Date of Event
    May 10, 2022
    Report Date
    August 3, 2022
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    UDI-DI
    05708932539203
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 NUMBER (6203745) WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. DEVICES MET SPECIFICATION PRIOR TO RELEASE AND NO TRENDS WERE NOTED.

    Additional Manufacturer Narrative · 0

    TITAN TOUCH PUMP WAS RECEIVED FOR EVALUATION. ABRASION WAS NOTED ON BOTH EXHAUST TUBES AND THE INLET TUBE OF THE PUMP. A SEPARATION, SURROUNDED BY ABRASION, WAS NOTED ON THE SHORTER EXHAUST TUBE OF THE PUMP AT THE STRAIN RELIEF JUNCTION. THIS IS A SITE OF LEAKAGE. BASED ON EXAMINATION OF THE RETURNED PRODUCT, IT WAS CONCLUDED THAT WHILE IN-VIVO BOTH THE EXHAUST TUBES AND INLET TUBE OF THE PUMP HAD OVERLAPPED AND ABRADED AGAINST ONE ANOTHER. THIS POSITIONING, IN COMBINATION WITH DEVICE USAGE OVER TIME, COULD CONTRIBUTE TO SUFFICIENT STRESS TO SEPARATE THE SHORTER EXHAUST TUBING AT THE STRAIN RELIEF JUNCTION. A SEPARATION OF THIS TYPE COULD THEN ALLOW THE LOSS OF FLUID, MAKING THE DEVICE INOPERABLE. 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.

    Description of Event or Problem · 0

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS EXPLANTED AND REPLACED DUE TO A TUBING FRACTURE ON THE WHITE TUBE JUST ABOVE THE PUMP. THE RESERVOIR AND PUMP WERE REPLACED WHILE THE ORIGINAL CYLINDERS WERE RETAINED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    ACCORDING TO AVAILABLE INFORMATION, THE PATIENT WITH THIS DEVICE EXPERIENCED PAIN AT THE SITE OF THE RESERVOIR PRIOR TO THE DEVICE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1475913 TITAN TOUCH INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S ES29222400 6203745 05708932539203

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention