BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN TOUCH SCRO ZERO ANG 22CM

    MDR report key: 8962018 · Received September 4, 2019

    Report

    Report Number
    2125050-2019-00717
    Event Type
    Injury
    Date Received
    September 4, 2019
    Date of Event
    August 5, 2019
    Report Date
    October 10, 2019
    Manufacturer
    NON-COLOPLAST
    Product Code
    FHW
    UDI-DI
    05708932539203
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP MDR IS CREATED TO DOCUMENT THE ADDITIONAL INFORMATION THAT INDICATED THE DEVICE IS NOT A COLOPLAST PRODUCT.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE REVIEW OF THE LOT NUMBER FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA REVIEW WAS COMPLETED. NO TRENDS 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, THE PLACEMENT OF THE CYLINDER WAS OUTSIDE THE CORPUS BODY. NO PRODUCT DEFECT WAS REPORTED. ADDITIONAL INFORMATION STATED "THE CYLINDER WAS NOT PLACED CORRECTLY. IT WAS NOT IN THE CORPORA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755537 TITAN TOUCH SCRO ZERO ANG 22CM INFLATABLE PENILE PROSTHESIS FHW NON-COLOPLAST ES29222400 6022127 05708932539203

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other