BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN OTR NAR SCRO 16CM

    MDR report key: 7264565 · Received February 12, 2018

    Report

    Report Number
    2125050-2018-00100
    Event Type
    Injury
    Date Received
    February 12, 2018
    Date of Event
    January 21, 2018
    Report Date
    June 6, 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

    THIS FOLLOW-UP MDR IS CREATED TO DOCUMENT THE CONCLUSION OF THE INVESTIGATION. A TITAN OTR PUMP, TWO CYLINDERS, AND A RESERVOIR WERE RECEIVED FOR EVALUATION. HOWEVER, BECAUSE QUALITY'S EXAMINATION MAY NOT CONCLUSIVELY CONFIRM OR DISPROVE THE REPORT OF EROSION AND EXPOSURE TO GLANS, 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. A REVIEW OF THE COMPLAINT HISTORY DATABASE REVEALED NO ADDITIONAL COMPLAINTS REPORTED FOR LOT 4241670. REVIEW OF NONCONFORMING REPORTS REVEALED NO NONCONFORMANCE'S WITH LOT 4241670 THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. NO CAPAS FOR ISSUES OF THIS TYPE ARE ASSOCIATED WITH LOT 4241670. 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 AND CYLINDER EXPOSURE TO GLANS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109059 TITAN OTR NAR SCRO 16CM INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S QNR9161022 4241670

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other