BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN TOUCH

    MDR report key: 11399370 · Received March 2, 2021

    Report

    Report Number
    2125050-2021-00176
    Event Type
    Injury
    Date Received
    March 2, 2021
    Date of Event
    December 30, 2020
    Report Date
    October 25, 2021
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    TITAN TOUCH PUMP, CYLINDERS 1 AND 2, RESERVOIR LOT # 7568999, RESERVOIR LOT # 7181016, AND DETACHED INLET TUBE WERE RECEIVED FOR EVALUATION. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH THE PUMP. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH EITHER CYLINDER. A SEPARATION WAS NOTED IN THE INLET TUBE OF THE RESERVOIR (LOT# 7568999). THIS WAS A SITE OF LEAKAGE. THE SURFACES APPEARED TO HAVE UNIFORM STRIATION, INDICATING CONTACT WITH SHARP INSTRUMENTATION. THE DETACHMENT END OF THE RESERVOIR (LOT# 7181016) STRAIN RELIEF AREA APPEARS TO HAVE ROUGH AND IRREGULAR EDGES, INDICATING STRESS WAS EXERTED. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH THIS RESERVOIR. THE DETACHMENT END OF THE RESERVOIR STRAIN RELIEF AREA APPEARS TO HAVE ROUGH AND IRREGULAR EDGES, INDICATING STRESS WAS EXERTED. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH THE INLET TUBE. BASED ON EXAMINATION OF THE RETURNED RESERVOIR (LOT # 7181016), IT WAS CONCLUDED THAT THE ROUGH AND IRREGULAR SURFACES ASSOCIATED WITH THE DETACHMENT ENDS OF THE INLET TUBE INDICATES THAT SUFFICIENT STRESS(S) MAY HAVE BEEN EXERTED ON THE INLET TUBE NEAR THE RESERVOIR TO SEPARATE THE SITE WHILE IN-VIVO. A SEPARATION OF THIS TYPE COULD THEN ALLOW THE LOSS OF FLUID, MAKING THE DEVICE INOPERABLE. IN ADDITION, TITAN TOUCH DEVICE (PUMP LOT #7289300, RESERVOIR LOT # 7568999) WAS RECEIVED WITH LOT # 7181016. EXAMINATION OF THE RETURNED DEVICE CONFIRMED A SEPARATION IN THE INLET TUBE OF THE RESERVOIR. TESTING REVEALED THIS TO BE A SITE OF LEAKAGE. MICROSCOPIC EXAMINATION OF THE SURFACES OF THE SEPARATION REVEALED UNIFORM STRIATION, INDICATING CONTACT WITH SHARP INSTRUMENTATION. BECAUSE THESE COMPONENTS WERE RELEASED ACCORDING TO MANUFACTURING AND QUALITY CONTROL PROCEDURES, IT WAS CONCLUDED THAT THE OBSERVED INSTRUMENT SEPARATION IN THE INLET TUBE OCCURRED SUBSEQUENT TO THE DEVICE PACKAGING BEING OPENED. IN ADDITION, BECAUSE NO FURTHER INFORMATION WAS RECEIVED AS TO THE REASON FOR THIS RETURN, QUALITY CONCLUDES 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.

    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 THE AVAILABLE INFORMATION, A RESERVOIR TUBING LEAK / TEAR OCCURRED. THE DEVICE WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295417 TITAN TOUCH INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S EN29181022 7289300

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention