BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN

    MDR report key: 13003608 · Received December 14, 2021

    Report

    Report Number
    2125050-2021-01768
    Event Type
    Injury
    Date Received
    December 14, 2021
    Date of Event
    May 23, 2021
    Report Date
    December 14, 2021
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT.

    Description of Event or Problem · 0

    AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, ADDING INFORMATION ABOUT THE RESERVOIR AND ASSEMBLY KIT USED TOGETHER WITH CYLINDERS: REVERVOIR: REF: (B)(4), LOT: 6883344; ASSEMBLY KIT: REF: (B)(4), LOT: 7559376. ATTACHING ANVISA'S TECHNOVIGILANCE REPORT AND TRANSLATION. IT WAS REPORTED BY OUR PARTNER DISTRIBUTOR (B)(4) THAT THE PATIENT DEVELOPED AN INFECTION APPROXIMATELY 3 MONTHS AFTER PENILE PROSTHESIS IMPLANTATION, REQUIRING PROSTHESIS REMOVAL (ALL COMPONENTS) AND PATIENT TREATMENT. THE PATIENT WAS TREATED WITHOUT MAJOR COMPLICATIONS OR DAMAGE TO HIS HEALTH AND REMAINED WITHOUT AN IMPLANT UNTIL THE IMPLANTATION OF A NEW ONE ON (B)(6) 2021. THE NEW IMPLANT HAS BEEN MONITORED BY THE DOCTOR AND HAS NOT HAD ANY PROBLEMS SO FAR. THE DISTRIBUTOR (B)(4) INFORMS THAT THE IMPLANT AND EXPLANT SURGERIES WERE FOLLOWED BY THE (B)(4) DISTRIBUTOR, WHICH IS NOT CURRENTLY OUR COMMERCIAL PARTNER. THEREFORE, IT WAS NOT POSSIBLE TO RECOVER THE EXPLANTED PROSTHESIS. NEITHER THE HOSPITAL NOR THE DOCTOR REPORTED THE EVENT TO HEALTH AUTHORITIES. THIS EVENT MUST BE REPORTED TO ANVISA. TRANSLATION OF THE MEDICAL REPORT ATTACHED: THE PATIENT HAS ICD10 DISEASE N48.4 (ERECTILE DYSFUNCTION OF ORGANIC ORIGIN) DIAGNOSED IN 2013 AND THE PATIENT WAS UNSUCCESSFULLY SUBMITTED TO ORAL AND INJECTABLE DRUG TREATMENT. HE UNDERWENT TITAN PENILE PROSTHESIS IMPLANT ON (B)(6) 2021. EVOLVED WITH HEMATOMA AND INFECTION REQUIRING REMOVAL OF THE PENILE PROSTHESIS ON (B)(6) 2021. HE SHOWED GOOD EVOLUTION, BUT MAINTAINED ERECTILE DYSFUNCTION. HE UNDERWENT A NEW TITAN INFLATABLE PENILE PROSTHESIS IMPLANT (HE HAS BEEN WITHOUT PROSTHESIS SINCE (B)(6) 2021) ON (B)(6) 2021. GOOD EVOLUTION AND MAINTAINS OUTPATIENT FOLLOW-UP. I AM AT YOUR DISPOSAL FOR ANY CLARIFICATIONS THAT MAY BE NECESSARY. SIGNED BY DR. (B)(6). DULY AUTHORIZED BY THE (B)(6) UNDER REGISTRATION NUMBER (B)(4). NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1895902 TITAN INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S ES29181022 6781631

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male