BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOUTHMEDIC #11 NON-STERILE DISPOSABLE SCALPEL

    MDR report key: 9750917 · Received February 25, 2020

    Report

    Report Number
    8022032-2019-00005
    Event Type
    Injury
    Date Received
    February 25, 2020
    Date of Event
    November 26, 2019
    Report Date
    January 3, 2020
    Manufacturer
    SOUTHMEDIC INC.
    Product Code
    GES
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER WAS NOTIFIED ON 12/13/2019 BY THE DISTRIBUTOR OF A COMPLAINT AGAINST SCALPEL 73-0211. THEY ADVISED THAT THEIR ALERT DATE WAS (B)(6) 2019 AND THEY HAVE NOT YET RECEIVED SAMPLES. SHOULD SAMPLES BE RECEIVED FROM THE DISTRIBUTOR, SOUTHMEDIC SHALL EVALUATE THEM FOR FURTHER INVESTIGATION. REVIEW OF BATCH RECORDS DEMONSTRATE THAT PART IS WITHIN SPECIFICATIONS. THE SUBMISSION DELAY OF THIS REPORT IS EXPLAINED IN ATTACHMENT 1.

    Description of Event or Problem · 1

    AS MEDICAL RESIDENT WENT TO REMOVE CLEAR PVC COVER TO SCALPEL, IT WAS STIFF AND REQUIRED EXTRA FORCE AND DURING REMOVAL, SLICED HIS FINGERS. RESIDENT VERY CAUTIOUS TO USE KIT NOW AND HOSPITAL NOW PROVIDING A SWANMORTON SINGLE USE SCALPEL - WHICH DOES NOT HAVE A COVER OVER IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213444 SOUTHMEDIC #11 NON-STERILE DISPOSABLE SCALPEL SCALPEL GES SOUTHMEDIC INC. 73-0211 102918

    Patients

    Seq Age Sex Outcome Treatment
    1 Other