BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOUTHMEDIC #11 NON-STERILE DISPOSABLE SCALPEL

    MDR report key: 9750899 · Received February 25, 2020

    Report

    Report Number
    8022032-2019-00004
    Event Type
    Injury
    Date Received
    February 25, 2020
    Date of Event
    November 1, 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 (B)(6) 2019 THAT THE DISTRIBUTOR RECEIVED 2 PRODUCT COMPLAINTS AGAINST SCALPEL 73-0211. THEY ADVISED THAT THEIR ALERT DATE WAS 11/01/19 AND THEY RECEIVED SAMPLES ON 11/21/19. SOUTHMEDIC RECEIVED THE SAMPLES FOR FURTHER INVESTIGATION. THE BATCH RECORD WAS REVIEWED AND SAMPLES WERE EVALUATED - NO ABNORMALITIES WERE DETECTED. THIS REPORT REPRESENTS THE 2ND COMPLAINT. ANOTHER REPORT HAS BEEN MADE FOR THE 1ST COMPLAINT (8022032-2019-00003).

    Description of Event or Problem · 1

    PHYSICIAN WAS CUT SEVERELY WHEN TRYING TO REMOVE THE COVER OFF OF THE SCALPEL. THE SCALPEL HAD NOT BEEN USED ON A PATIENT YET. THE PHYSICIAN WENT TO THE ER FOR TREATMENT. THE NURSE WHO REPORTED STATED THE COVER SEEMED DIFFICULT TO REMOVE AND THE INCIDENT OCCURED WHEN THE PHYSICIAN APPLIED FORCE TO REMOVE THE COVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213437 SOUTHMEDIC #11 NON-STERILE DISPOSABLE SCALPEL SCALPEL GES SOUTHMEDIC INC. 73-0211 040419

    Patients

    Seq Age Sex Outcome Treatment
    1 Other