BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DBD-SHOULDER ARTHROSCOPY PACK-LF

    MDR report key: 11684743 · Received April 19, 2021

    Report

    Report Number
    1423395-2021-00019
    Event Type
    Injury
    Date Received
    April 19, 2021
    Date of Event
    March 1, 2021
    Report Date
    April 29, 2021
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    OJH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN UNUSED DRAPE SAMPLE WAS RETURNED BY THE REPORTING FACILITY FOR INVESTIGATION. SAMPLE INVESTIGATION WAS COMPLETED ON (B)(6) 2021. THE RETURNED SAMPLE WAS MEASURED AND FOUND TO MEET PRODUCT SPECIFICATIONS. NO ISSUE WAS IDENTIFIED WITH THE RETURNED UNUSED SAMPLE AND THE ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE ANOTHER SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT A "MASSIVE AMOUNT OF FLUID" SPILLED OFF OF THE DRAPE AND ONTO THE FLOOR DURING USE. REPORTEDLY, A STAFF MEMBER SLIPPED ON THE FLUID, FELL, AND EXPERIENCED "ELECTROCUTION." DESPITE MULTIPLE GOOD FAITH ATTEMPTS, THE CUSTOMER WAS UNABLE OR UNWILLING TO PROVIDE ANY ADDITIONAL INFORMATION RELATED TO THE REPORTED INCIDENT. IT IS UNKNOWN WHAT PROCEDURE WAS BEING PERFORMED AT THE TIME OF THE INCIDENT, WHAT ELECTRONIC/ELECTRIC DEVICE WAS IN USE DURING THE PROCEDURE, WHAT MEDICAL INTERVENTION OR FOLLOW-UP CARE WAS NEEDED, AND WHAT THE STAFF MEMBER'S CURRENT STATUS IS. NO PATIENT IMPACT WAS ORIGINALLY REPORTED. THE USED PROCEDURE PACK WAS ORIGINALLY REPORTED AS BEING DISCARDED AND THE SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. DUE TO THE REPORTED INCIDENT, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A "MASSIVE AMOUNT OF FLUID" SPILLED OFF OF THE DRAPE AND ONTO THE FLOOR DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586538 DBD-SHOULDER ARTHROSCOPY PACK-LF OJH MEDLINE INDUSTRIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other