BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESP

    MDR report key: 8080099 · Received November 16, 2018

    Report

    Report Number
    2134265-2018-62841
    Event Type
    Malfunction
    Date Received
    November 16, 2018
    Date of Event
    October 1, 2018
    Report Date
    November 16, 2018
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    IWP
    UDI-DI
    08714729735175
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: THE EVENT DATE WAS NOT REPORTED; THE FIRST DATE OF THE MONTH OF THE AWARE DATE WAS SELECTED AS AN ESTIMATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SEVERAL PAIRS OF SIZE 8 ESP SPECIALTY GLOVES HAD BEEN OPENED AND EVERY PAIR HAD A HOLE IN THE WRIST. THERE WERE NO PATIENT OR PHYSICIAN INJURIES OR ISSUES REPORTED TO HAVE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918699 ESP GLOVE, PATIENT EXAMINATION, SPECIALTY IWP BOSTON SCIENTIFIC CORPORATION 37415 0020986742 08714729735175

    Patients

    Seq Age Sex Outcome Treatment
    1