BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN TOUCH

    MDR report key: 14973714 · Received July 9, 2022

    Report

    Report Number
    2125050-2022-00714
    Event Type
    Injury
    Date Received
    July 9, 2022
    Report Date
    December 13, 2022
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 (4860627) WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. DEVICES MET SPECIFICATION PRIOR TO RELEASE AND NO TRENDS WERE NOTED. DATE OF OCCURRENCE NOT REPORTED BUT ESTIMATED TO BE IN (B)(6) 2022.

    Additional Manufacturer Narrative · 0

    TITAN TOUCH PUMP, CYLINDERS 1 AND 2, AND DETACHED CONNECTOR / INLET TUBING WERE RECEIVED FOR EVALUATION. ABRASION WAS NOTED ON THE SHORTER EXHAUST TUBE AND THE INLET TUBE OF THE PUMP. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH THE PUMP. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH CYLINDER 1. A SEPARATION WAS NOTED ON THE EXHAUST TUBE OF THE CYLINDER 2, NEAR THE STRAIN RELIEF JUNCTION. THIS IS A SITE OF LEAKAGE. THE SURFACES APPEAR TO HAVE CREASE MARKS ADJACENT TO OR WITHIN A CONFINED AREA OF ABRASION, INDICATING THE AREA WAS KINKED AND ABRADING AGAINST ITSELF FOR AN EXTENDED PERIOD OF TIME. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH THE DETACHED INLET TUBING OR THE CONNECTOR. BASED ON EXAMINATION OF THE RETURNED PRODUCT, IT WAS CONCLUDED THAT THE ABRASION MARKS NOTED ON THE SHORTER PUMP EXHAUST TUBING AND PUMP INLET TUBING MATCHED IN SUCH A WAY TO CONCLUDE THAT THEY HAD OVERLAPPED AND ABRADED AGAINST ONE ANOTHER WHILE IN-VIVO. THIS THEN MAY HAVE CAUSED THE EXHAUST TUBE OF CYLINDER 2 TO BE KINKED ONTO ITSELF FOR A PERIOD OF TIME. THIS POSITIONING, IN COMBINATION WITH DEVICE USAGE OVER TIME, COULD CONTRIBUTE TO SUFFICIENT STRESS TO SEPARATE THE EXHAUST TUBING. 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 EXPERIENCED A MALFUNCTION DUE TO FAILURE OF THE PUMP TO INFLATE THE CYLINDERS. REVISION SURGERY SCHEDULED FOR (B)(6) 2022. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2015950 TITAN TOUCH INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S ES29201022 4860627

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Male Required Intervention