BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOROSA SALINE TESTICULAR MED

    MDR report key: 7500406 · Received May 9, 2018

    Report

    Report Number
    2125050-2018-00360
    Event Type
    Injury
    Date Received
    May 9, 2018
    Date of Event
    April 10, 2018
    Report Date
    July 10, 2018
    Manufacturer
    COLOPLAST A/S
    Product Code
    FAF
    UDI-DI
    05708932470834
    PMA / PMN Number
    P020003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. ONCE OUR EVALUATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP MDR IS CREATED TO DOCUMENT THE EVALUATION OF THE RETURNED DEVICE. ONE TOROSA TESTICULAR IMPLANT WAS RECEIVED FOR EVALUATION. EXAMINATION AND TESTING OF THE RETURNED COMPONENTS REVEALED A SEPARATION IN THE SUTURE TAB OF THE PROSTHESIS. TESTING REVEALED THIS NOT TO BE A SITE OF LEAKAGE. THE SEPARATION APPEARS TO BE ROUGH AND IRREGULAR, INDICATING SUFFICIENT STRESS WAS EXERTED. BASED ON THE INFORMATION RECEIVED AND QUALITY'S EXAMINATION, QUALITY CONCLUDES THAT STRESS WAS EXERTED ON THE SUTURE TAB OF THE PROSTHESIS DUE TO THE TIED SUTURE, CAUSING SEPARATION IN THE TAB. THIS COULD THEN ALLOW FOR THE TESTICULAR IMPLANT TO MOVE FROM ITS INTENDED POSITION. QUALITY CANNOT DETERMINE WHEN THIS SEPARATION OCCURRED. 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 FOR LOT 4083537. REVIEW OF NONCONFORMING REPORTS REVEALED NO NONCONFORMANCE'S FOR THIS LOT. NO CAPAS ARE ASSOCIATED WITH THIS LOT. 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 THE AVAILABLE INFORMATION, IMPLANT WAS MIGRATING, HAD BEEN TIED DOWN AT SURGERY AND ONCE INCISION WAS MADE, IMPLANT SURFACE. THE TIED DOWN TAB WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343779 TOROSA SALINE TESTICULAR MED SALINE FILLED TESTICULAR PROSTHESIS FAF COLOPLAST A/S 5206302400 4083537 05708932470834

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other