BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTIS KIT

    MDR report key: 8481158 · Received April 3, 2019

    Report

    Report Number
    2125050-2019-00237
    Event Type
    Injury
    Date Received
    April 3, 2019
    Report Date
    June 25, 2019
    Manufacturer
    COLOPLAST CORP
    Product Code
    PAH
    PMA / PMN Number
    K121562
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 CONCLUSION OF THE INVESTIGATION, UPDATE CODES AND ADDITIONAL INFORMATION. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE DEVICES FROM THIS LOT MET ALL SPECIFICATIONS PRIOR TO RELEASE. A REVIEW OF THE COMPLAINT HISTORY DATABASE, NONCONFORMANCES AND CAPAS REVEALED NO TRENDS FOR THIS LOT. THE CM HAS BEEN NOTIFIED OF THE REPORTED COMPLAINT.

    Description of Event or Problem · 1

    ACCORDING TO THE AVAILABLE INFORMATION, MESH POKED THROUGH NEAR MID-INCISION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED, THE PHYSICIAN INDICATED HE USES THE SAME TECHNIQUE AND SURGICAL PROTOCOL FOR EACH OF HIS ALTIS PATIENTS. HE INDICATED HE DOES NOT PERFORM A COUGH/LEAK TEST. HE THEORIZED THAT THE CAUSE OF THE EXTRUSION COULD BE INFECTION, BUT INFECTION COULD NOT BE CONFIRMED. HISTORY OF SMOKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270256 ALTIS KIT SURGICAL MESH PAH COLOPLAST CORP 5196502400 5903772

    Patients

    Seq Age Sex Outcome Treatment
    1 Other