BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN TOUCH

    MDR report key: 14378163 · Received May 12, 2022

    Report

    Report Number
    2125050-2022-00505
    Event Type
    Injury
    Date Received
    May 12, 2022
    Date of Event
    April 1, 2022
    Report Date
    July 26, 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 (7915603) 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, AND RESERVOIR WERE RECEIVED FOR EVALUATION. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH THE PUMP. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH CYLINDER 1. ABRASION WAS NOTED ON THE EXHAUST TUBING OF CYLINDER 2. A SEPARATION WAS NOTED ON THE EXHAUST TUBE OF CYLINDER 2. THIS IS A SITE OF LEAKAGE. THE SEPARATION HAS A CENTRAL GROOVE, INDICATING CONTACT WITH SHARP INSTRUMENTATION SUCH AS A NEEDLE. A GROUP OF STRIATIONS, INDICATING CONTACT WITH UNSHOD INSTRUMENTATION, WERE NOTED ON THE STRAIN RELIEF OF THE RESERVOIR. THIS IS NOT A SITE OF LEAKAGE. NO FUNCTIONAL ABNORMALITIES WERE NOTED ON THE RESERVOIR. BECAUSE THESE COMPONENTS WERE RELEASED ACCORDING TO MANUFACTURING AND QUALITY CONTROL PROCEDURES, IT WAS CONCLUDED THAT THE OBSERVED NEEDLE SEPARATION IN THE EXHAUST TUBE OF CYLINDER 2 OCCURRED SUBSEQUENT TO THE DEVICE PACKAGING BEING OPENED. THE INFORMATION RECEIVED INDICATED THAT THE DEVICE HAD BEEN IMPLANTED ONLY A SHORT TIME BEFORE THE REPORTED EVENT WAS NOTED. BASED ON THE EVALUATION AND INFORMATION RECEIVED, THE SEPARATION MOST LIKELY OCCURRED INADVERTENTLY DURING THE IMPLANT PROCEDURE. 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 FAILURE TO INFLATE AND AN EMPTY RESERVOIR. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2041250 TITAN TOUCH INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S ES28201022 7915603

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male Required Intervention