BEUDAMED
    FDA Adverse Event Injury Summary report: N

    (OUT)TITAN OTR NAR SCRO 14CM

    MDR report key: 7270087 · Received February 14, 2018

    Report

    Report Number
    2125050-2018-00162
    Event Type
    Injury
    Date Received
    February 14, 2018
    Date of Event
    June 1, 2017
    Report Date
    April 26, 2018
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 OF CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    AN OTR PUMP, TWO CYLINDERS AND A RESERVOIR WERE RECEIVED FOR EVALUATION. BECAUSE QUALITY'S EXAMINATION OF THE RETURNED COMPONENTS MAY NOT CONCLUSIVELY CONFIRM OR DISPROVE THE REPORT OF INFECTION, QUALITY DID NOT PERFORM A MICROSCOPIC EXAMINATION. BASED ON THE INFORMATION PROVIDED, QUALITY ACCEPTS THE PHYSICIAN'S OBSERVATIONS OF SUCH AS THE REASON FOR SURGICAL INTERVENTION. THE REVIEW OF THE DEVICE LOT HISTORY RECORDS BY QUALITY ASSURANCE INDICATES THIS LOT PASSED STERILITY TESTING PRIOR TO BEING RELEASED. BASED ON THIS KNOWLEDGE, QUALITY CONCLUDES THAT THE DEVICE WAS STERILE PRIOR TO THE DEVICE PACKAGING BEING OPENED AND THAT THE INFECTION ORIGINATED FROM SOURCE(S) OTHER THAN THE DEVICE. MANAGEMENT ROUTINELY REVIEWS EVENTS SUCH AS THIS AND MONITORS COMPLAINT LEVELS. ADDITIONALLY, EVENTS OF THIS TYPE ARE CAPTURED IN THE PRODUCT RISK DOCUMENTATION. BASED ON THIS INFORMATION NO FURTHER CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    ACCORDING TO AVAILABLE INFORMATION, INFECTION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114367 (OUT)TITAN OTR NAR SCRO 14CM INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S QNR9141002 4021119

    Patients

    Seq Age Sex Outcome Treatment
    1 Other