BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LSRHKGYN

    MDR report key: 7884758 · Received September 18, 2018

    Report

    Report Number
    7884758
    Event Type
    Malfunction
    Date Received
    September 18, 2018
    Date of Event
    August 22, 2018
    Report Date
    September 5, 2018
    Manufacturer
    LEESAR, INC.
    Product Code
    OHD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    OPERATING ROOM STAFF FOUND ISSUES WITH MULTIPLE LEESAR CUSTOM PACKS. PN LSRHHMINORD- 1PK OF 4X4 X-RAY 16-PLY LEFT OUT (LOT# 921181); PN LSRHHGYNLAC- 4X4 X-RAY, 16-PLY HAD 12 INSTEAD OF 10 (LOT# 876181); PN LSRHHGYNLAC- 4X4 X-RAY, 16-PLY HAD 8 INSTEAD OF 10 (LOT# 876181); PN LSRHHTOHIPB- HAS HAIR IN THE PACK, PACK IS UNOPENED (LOT# 900181). LN 3861000 INCORRECT RAYTEX COUNT; THE PACK HAD A TOTAL OF TWO PACKS INSTEAD OF ONE (LOT#834181).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727131 LSRHKGYN GYNECOLOGICAL LAPAROSCOPIC KIT OHD LEESAR, INC. 921181, 876181, 900181, 834181

    Patients

    Seq Age Sex Outcome Treatment
    1