BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITAN INFLATABLE PENILE PROSTHESIS FAMILY

    MDR report key: 23123896 · Received September 23, 2025

    Report

    Report Number
    2125050-2025-01518
    Event Type
    Malfunction
    Date Received
    September 23, 2025
    Date of Event
    September 2, 2025
    Report Date
    October 25, 2025
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    UDI-DI
    05701780272957
    PMA / PMN Number
    P000006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PICTURE WAS PROVIDED IN WHICH THE LABEL CAN BE VERIFIED AS HAVING THE INCORRECT INFORMATION. UPON LOT REVIEW, THERE WAS 1 OTHER IDENTIFIED COMPLAINT ON THIS LOT FOR THE SAME ALLEGED ISSUE. ADDITIONALLY, THERE WAS A NC AND CAPA IDENTIFIED THAT IS ASSOCIATED WITH THIS LOT AND ALLEGED ISSUE. THE NC AND CAPA WERE LAUNCHED AS A RESULT OF THE PREVIOUS COMPLAINT FILE INVESTIGATION IDENTIFYING A NONCONFORMITY. A MANUFACTURING INVESTIGATION WAS INITIATED VERIFYING THIS COMPLAINT FALLS WITHIN THE SCOPE OF NC AND CAPA. AS PART OF THE NC PROCESS, A HISTORIC HHE HAD BEEN INITIATED AS PRODUCT WAS IN THE FIELD THE HHE DOCUMENTED LOT 9185146 HAD A TOTAL OF 10 UNITS MANUFACTURED AND CONCLUDED THAT THE INCORRECT LABELLING APPLIES TO THE ENTIRE LOT. THEREFORE, ALL UNITS FROM LOT 9185146 ARE EXPECTED TO EXHIBIT THE FAILURE. HHE CONCLUSION WAS "USE AS IS" FOR PRODUCT IN THE FIELD. THE RECEIPT OF AN ADDITIONAL COMPLAINT (COMP-(B)(4) IS ALIGNED WITH THE ANTICIPATED OCCURRENCE RATE DOCUMENTED IN THE HHE AND DOES NOT CHANGE THE RISK ASSESSMENT. A MEMO TO FILE FOR THE ASSOCIATED HHE WILL BE COMPLETED TO DOCUMENT THE ADDITIONAL COMPLAINT.

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING [NC] REPORT AND CAPA. THERE WAS 1 OTHER IDENTIFIED COMPLAINT ON THIS LOT FOR THE SAME ALLEGED ISSUE. ADDITIONALLY, THERE WAS A NC AND CAPA IDENTIFIED THAT IS ASSOCIATED WITH THIS LOT AND ALLEGED ISSUE. A MANUFACTURING INVESTIGATION WILL BE INITIATED TO IDENTIFY IF THIS COMPLAINT HAS ANY IMPACT TO THE SCOPE.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, THE HOSPITAL WENT TO USE A ES2914 AND WHILE THE OUTER BOX WAS CORRECTLY LABELED AS ES2914, THE BARCODE ON THE INNER BOX INDICATED ES2916. UPON OPENING THE BOX, THE IMPLANT INSIDE WAS A ES2914. THE STICKER BARCODES INCLUDED IN THE PACKAGE INCLUDED 7 LABELS FOR ES2916 AND ATTACHED NEXT TO THEM, A LABEL FOR ES2914. THIS DID NOT CAUSE ANY ISSUE FOR THE SURGEON OR THE HOSPITAL.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, THE HOSPITAL WENT TO USE A ES2914 AND WHILE THE OUTER BOX WAS CORRECTLY LABELED AS ES2914, THE BARCODE ON THE INNER BOX INDICATED ES2916. UPON OPENING THE BOX, THE IMPLANT INSIDE WAS A ES2914. THE STICKER BARCODES INCLUDED IN THE PACKAGE INCLUDED 7 LABELS FOR ES2916 AND ATTACHED NEXT TO THEM, A LABEL FOR ES2914. THIS DID NOT CAUSE ANY ISSUE FOR THE SURGEON OR THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201221 TITAN INFLATABLE PENILE PROSTHESIS FAMILY PENILE PROSTHESIS, INFLATABLE FHW COLOPLAST A/S 9185146_ES29144022 05701780272957

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown