BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN TOUCH

    MDR report key: 13638035 · Received March 1, 2022

    Report

    Report Number
    2125050-2022-00187
    Event Type
    Injury
    Date Received
    March 1, 2022
    Date of Event
    February 10, 2022
    Report Date
    May 5, 2022
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 (6781608) 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, CYLINDERS 1 AND 2, RESERVOIR, AND DETACHED CONNECTOR / INLET TUBING WERE RECEIVED FOR EVALUATION. ABRASION WAS NOTED ON BOTH EXHAUST TUBES OF THE PUMP. PARTIAL SEPARATIONS, SURROUNDED BY ABRASION, WERE NOTED ON ONE OF THE EXHAUST TUBES OF THE PUMP. THESE WERE NOT SITES OF LEAKAGE. A SEPARATION, SURROUNDED BY ABRASION, WAS NOTED ON THE SAME EXHAUST TUBE. THIS IS A SITE OF LEAKAGE. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH CYLINDER 1. A SEPARATION WAS NOTED ON THE BLADDER OF CYLINDER 2. THIS IS A SITE OF LEAKAGE. THE SEPARATION HAS A CENTRAL GROOVE, INDICATING CONTACT WITH SHARP INSTRUMENTATION SUCH AS A NEEDLE. ABRASION WAS NOTED ON THE INLET TUBING OF THE RESERVOIR. PARTIAL SEPARATIONS, SURROUNDED BY ABRASION, WERE NOTED ON THE INLET TUBE OF THE RESERVOIR. THESE WERE NOT SITES OF LEAKAGE. A GROUP OF STRIATIONS, INDICATING CONTACT WITH UNSHOD INSTRUMENTATION, WAS NOTED ON THE INLET TUBE OF THE RESERVOIR. THIS IS A SITE OF LEAKAGE. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH THE PIECE OF DETACHED INLET TUBING OR CONNECTOR. BASED ON EXAMINATION OF THE RETURNED PRODUCT, IT WAS CONCLUDED THAT THE ABRASION MARKS NOTED ON BOTH EXHAUST TUBES OF THE PUMP MATCHED IN SUCH A WAY TO CONCLUDE THAT THEY HAD OVERLAPPED AND ABRADED AGAINST ONE ANOTHER WHILE IN-VIVO ENOUGH TO CAUSE A SEPARATION IN ONE OF THE EXHAUST TUBES. A SEPARATION OF THIS TYPE COULD THEN ALLOW THE LOSS OF FLUID, MAKING THE DEVICE INOPERABLE. BECAUSE THESE COMPONENTS WERE RELEASED ACCORDING TO MANUFACTURING AND QUALITY CONTROL PROCEDURES, IT WAS CONCLUDED THAT THE OBSERVED INSTRUMENT SEPARATIONS IN THE BLADDER OF CYLINDER 2 AND INLET TUBING OF THE RESERVOIR OCCURRED AFTER THE DEVICE PACKAGING WAS OPENED. IN ADDITION, BECAUSE THE EXPECTED USE OF THIS DEVICE COMBINED WITH THE OBSERVED SEPARATIONS WOULD HAVE RESULTED IN AN EARLIER DETECTED FLUID LOSS, IT WAS CONCLUDED THAT THE SEPARATIONS MOST LIKELY OCCURRED DURING OR AFTER EXPLANT. THESE SEPARATIONS ARE NOT ASSOCIATED WITH THE CAUSE FOR FAILURE. 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 TUBING LEAKAGE AT THE PUMP EXHAUST TUBE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1011652 TITAN TOUCH INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S EN29161022 6781608

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention