BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOUTHMEDIC #10 STERILE SAFETY SCALPEL

    MDR report key: 7742332 · Received August 2, 2018

    Report

    Report Number
    8022032-2018-00004
    Event Type
    Injury
    Date Received
    August 2, 2018
    Date of Event
    January 25, 2018
    Report Date
    June 27, 2018
    Manufacturer
    SOUTHMEDIC, INC.
    Product Code
    GES
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS INITIALLY DEEMED NOT REPORTABLE BY SOUTHMEDIC INC. IT WAS DETERMINED THAT THE USER DID NOT FOLLOW INSTRUCTIONS FOR RETRACTION OF THE SAFETY GUARD. THE USER FACILITY REPORTED THE INCIDENT THROUGH THE MEDWATCH PROGRAM, HOWEVER THIS ADDITIONAL INFORMATION WAS NOT RELAYED TO THE REGULATORY DEPARTMENT AT THE MANUFACTURING FACILITY, WHICH WOULD HAVE PROMPTED A REVIEW OF THE REPORTING REQUIREMENTS FOR THIS INCIDENT. EFFORTS WERE MADE TO INCREASE AWARENESS OF REPORTING REQUIREMENTS WITH PERSONNEL INVOLVED IN COMPLAINT HANDLING. IN (B)(4) 2018. ADDITIONAL COMPLAINTS WERE RECEIVED WHERE USERS CUT THEMSELVES ATTEMPTING TO REMOVE THE GUARD FROM SOUTHMEDIC SCALPELS. THE INCREASED FREQUENCY OF THESE COMPLAINTS, AND CONSULTATION WITH CLINICAL EXPERTS, LED TO THE DECISION THAT THESE INCIDENCES SHOULD BE REPORTED.

    Description of Event or Problem · 1

    REPORT FROM THE USER FACILITY: "ONE OF OUR PHYSICIANS CUT HIS HAND TRYING TO PULL BACK THE PROTECTIVE SHIELD BEFORE USE. THE SHIELD DID NOT PULL BACK EASILY USING THE TOP OF THE SCALPEL AND ONE FINGER AND IT LOOKS LIKE THE PHYSICIAN HAD TO USE HIS THUMB AND FINGER TO GRIP THE SHIELD ON THE SIDES, LEADING TO THE INJURY. " THIS EVENT WAS REPORTED THROUGH THE FDA MEDWATCH PROGRAM BY THE USER FACILITY UNDER MW5075057.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584068 SOUTHMEDIC #10 STERILE SAFETY SCALPEL SAFETY SCALPEL GES SOUTHMEDIC, INC. 73-0610 110917

    Patients

    Seq Age Sex Outcome Treatment
    1 Other