BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN TOUCH

    MDR report key: 14553773 · Received May 31, 2022

    Report

    Report Number
    2125050-2022-00570
    Event Type
    Injury
    Date Received
    May 31, 2022
    Date of Event
    May 12, 2022
    Report Date
    August 10, 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 (7180052) 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 AND CYLINDERS 1 AND 2 WERE RECEIVED FOR EVALUATION. ABRASION WAS NOTED ON BOTH EXHAUST TUBES AND THE INLET TUBE OF THE PUMP. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH THE PUMP. A SEPARATION WAS NOTED ON THE EXHAUST TUBE OF CYLINDER 2. THIS IS A SITE OF LEAKAGE. THE SEPARATION HAS A SMOOTH, STRAIGHT EDGE, INDICATING CONTACT WITH SHARP INSTRUMENTATION. A SEPARATION WAS NOTED ON THE BLADDER OF CYLINDER 1. THIS IS A SITE OF LEAKAGE. THE SEPARATION HAS A SMOOTH, STRAIGHT EDGE, INDICATING CONTACT WITH SHARP INSTRUMENTATION. A SEPARATION WAS ALSO NOTED ON THE EXHAUST TUBING OF CYLINDER 1. THIS IS NOT A SITE OF LEAKAGE. THE SEPARATION HAS A SMOOTH, STRAIGHT EDGE, INDICATING CONTACT WITH SHARP INSTRUMENTATION. THE INFORMATION RECEIVED INDICATED THE DEVICE HAD LEAKAGE AT THE PUMP EXHAUST TUBING, BUT BECAUSE NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH THE RETURNED COMPONENTS OTHER THAN INSTRUMENT DAMAGE, THE COMPLAINT COULD NOT BE CONFIRMED AS REPORTED. BECAUSE THESE COMPONENTS WERE RELEASED ACCORDING TO MANUFACTURING AND QUALITY CONTROL PROCEDURES, IT WAS CONCLUDED THAT THE OBSERVED INSTRUMENT SEPARATIONS ON THE BLADDER OF CYLINDER 1, EXHAUSTING OF CYLINDER 1 AND EXHAUST TUBING OF CYLINDER 2 OCCURRED AFTER THE DEVICE PACKAGING WAS OPENED. IN ADDITION, BECAUSE THE EXPECTED USE OF THIS DEVICE COMBINED WITH THE OBSERVED SEPARATION WOULD HAVE RESULTED IN AN EARLIER DETECTED FLUID LOSS, IT WAS CONCLUDED THAT THE SEPARATION MOST LIKELY OCCURRED DURING OR AFTER EXPLANT. THIS SEPARATION IS 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 NOTED AT THE PUMP EXHAUST TUBE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1731971 TITAN TOUCH INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S EN29141022 7180052

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention