BEUDAMED
    FDA Adverse Event Injury Summary report: N

    (OUT)TITAN OTR NAR SCRO 16CM

    MDR report key: 7269793 · Received February 14, 2018

    Report

    Report Number
    2125050-2018-00122
    Event Type
    Injury
    Date Received
    February 14, 2018
    Date of Event
    April 12, 2017
    Report Date
    April 9, 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

    A TITAN OTR PUMP AND TWO CYLINDERS WERE RECEIVED FOR EVALUATION. BECAUSE QUALITY'S EXAMINATION OF THE RETURNED COMPONENTS MAY NOT CONCLUSIVELY CONFIRM OR DISPROVE THE REPORT OF EROSION, 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. QUALITY REVIEWED THE MANUFACTURING RECORDS FOR THIS DEVICE AND CONFIRMED THAT THERE WERE NO DISCREPANCIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT AND VERIFIED THAT THE DEVICES FROM THIS LOT MET ALL SPECIFICATIONS PRIOR TO RELEASE. REVIEW OF NONCONFORMANCES REVEALED NO NONCONFORMANCE WITH THIS LOT THAT WOULD HAVE CONTRIBUTED TO THE EVENT. 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, EROSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113089 (OUT)TITAN OTR NAR SCRO 16CM INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S QNR9161002 4028711

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other