BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PSI-TEC III ASPIRATOR, 110V

    MDR report key: 11713052 · Received April 23, 2021

    Report

    Report Number
    1645337-2021-04412
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    March 31, 2021
    Report Date
    April 6, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    MUU
    UDI-DI
    00081317023364
    PMA / PMN Number
    K981215
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 4/29/2021, THE MANUFACTURING RECORD EVALUATION (MRE) OF LOT NUMBER 04-050108 WAS REQUESTED TO THE QUALITY OPERATIONS TEAM. HOWEVER, THE PHYSICAL FILE OF THE DHR WAS NOT FOUND. ONCE MORE INFORMATION IS AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS CAN BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, THE INVESTIGATION WILL BE REOPENED AND CONDUCTED AS APPROPRIATE. A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: NOT APPLICABLE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PSI-TEC III ASPIRATOR, 110V BEING USED IN AN UNSPECIFIED PROCEDURE WAS FOUND TO HAVE SUCTION ISSUES (NO SUCTION PRESSURE) DURING THE OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT, AND THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609863 PSI-TEC III ASPIRATOR, 110V SYSTEM, SUCTION, LIPOPLASTY MUU MENTOR TEXAS PT-ASP-III-110 00081317023364

    Patients

    Seq Age Sex Outcome Treatment
    1