BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTIS KIT

    MDR report key: 6346983 · Received February 21, 2017

    Report

    Report Number
    2125050-2017-00026
    Event Type
    Injury
    Date Received
    February 21, 2017
    Date of Event
    February 16, 2017
    Report Date
    September 19, 2017
    Manufacturer
    COLOPLAST A/S
    Product Code
    PAH
    PMA / PMN Number
    K121562
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    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 WAS RECEIVED FOR EVALUATION. EXAMINATION AND TESTING OF THE RETURNED COMPONENT REVEALED NO FUNCTIONAL ABNORMALITIES NOTED WITH THE PUMP. THE INFORMATION RECEIVED INDICATED ""KINK" IN PUMP - VERY STIFF AND RIGID - IMPOSSIBLE TO INFLATE", BUT BECAUSE NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH THE RETURNED COMPONENTS, QUALITY CANNOT CONFIRM THE COMPLAINT AS REPORTED. 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 PATIENT EXPERIENCED PERSISTENT LEG PAIN. PATIENT REPORTED SHE COULD NOT MOVE HER LEG WITHOUT PAIN. NO PAIN WHEN LYING DOWN. PHYSICIAN DETERMINED THAT HE OVER ROTATED THE INTRODUCER ON THE DYNAMIC SIDE AND PLACED ANCHOR IN ADDUCTOR MAGNUS AND THE TENSION ON THE SLING WAS CAUSING THE PAIN WHEN MOVING HER LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128883 ALTIS KIT SURGICAL MESH PAH COLOPLAST A/S 5196502400

    Patients

    Seq Age Sex Outcome Treatment
    1 Other