BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHEARGUARD CHEST PAD COVERS

    MDR report key: 8509085 · Received April 12, 2019

    Report

    Report Number
    2921578-2019-00015
    Event Type
    Injury
    Date Received
    April 12, 2019
    Date of Event
    January 8, 2019
    Report Date
    August 28, 2019
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    KME
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UNABLE TO DETERMINE IF THE PATIENT HAD COMORBIDITIES THAT COULD HAVE CONTRIBUTED TO THE PROBLEM. ADVISED THE DISTRIBUTOR TO DISCUSS THE OWNER'S MANUAL POSITIONING INSTRUCTIONS WITH THE CUSTOMER. THIS PROBLEM WAS INITIALLY REPORTED AS RELATED TO THE PROAXIS TABLE. INVESTIGATION FOUND IT MIGHT ALSO BE RELATED TO THE TWO SINGLE-USE PAD COVERS, SO TWO ADDITIONAL REPORTS ARE BEING FILED SHOWING THE POSSIBLE ASSOCIATION OF THE INJURY WITH THOSE TWO DEVICES. FURTHER INFORMATION RECEIVED FROM THE DISTRIBUTOR REVEALED THAT THIS INCIDENT IS THE SAME ONE REPORTED AS 2921578-2019-0010.

    Description of Event or Problem · 0

    PATIENT WAS POSITIONED PRONE FOR POSTERIOR APPROACH SURGERY UTILIZING THE STANDARD PROAXIS SPINE ASSEMBLY (OPEN FRAME/SPARS) CONFIGURED WITH TORSO TROLLEY, ARM BOARDS, CHEST/PELVIC BOLSTERS AND LEG SUPPORT. ALL ITEMS WERE COVERED PRIOR TO THE PROCEDURE WITH THE RECOMMENDED OSI SHEAR PROTECT CONSUMABLES TO MINIMIZE RISK OF SKIN INJURY. POSTOPERATIVELY, THE CLIENT PRESENTED WITH PRESSURE RELATED SORES UNDER AREAS OF CONTACT AROUND STERNUM AND ASIS. IT WAS NOTED THAT BMI AND LENGTH OF CASE (UP TO 13 HOURS) COULD HAVE BEEN CONTRIBUTING FACTORS.

    Additional Manufacturer Narrative · 1

    UNABLE TO DETERMINE IF THE PATIENT HAD COMORBIDITIES THAT COULD HAVE CONTRIBUTED TO THE PROBLEM. ADVISED THE DISTRIBUTOR TO DISCUSS THE OWNER'S MANUAL POSITIONING INSTRUCTIONS WITH THE CUSTOMER. THIS PROBLEM WAS INITIALLY REPORTED AS RELATED TO THE PROAXIS TABLE. INVESTIGATION FOUND IT MIGHT ALSO BE RELATED TO THE TWO SINGLE-USE PAD COVERS, SO TWO ADDITIONAL REPORTS ARE BEING FILED SHOWING THE POSSIBLE ASSOCIATION OF THE INJURY WITH THOSE TWO DEVICES.

    Description of Event or Problem · 1

    PATIENT WAS POSITIONED PRONE FOR POSTERIOR APPROACH SURGERY UTILIZING THE STANDARD PROAXIS SPINE ASSEMBLY (OPEN FRAME/SPARS) CONFIGURED WITH TORSO TROLLEY, ARM BOARDS, CHEST/PELVIC BOLSTERS AND LEG SUPPORT. ALL ITEMS WERE COVERED PRIOR TO THE PROCEDURE WITH THE RECOMMENDED OSI SHEAR PROTECT CONSUMABLES TO MINIMIZE RISK OF SKIN INJURY. POSTOPERATIVELY, THE CLIENT PRESENTED WITH PRESSURE RELATED SORES UNDER AREAS OF CONTACT AROUND STERNUM AND ASIS. IT WAS NOTED THAT BMI AND LENGTH OF CASE (UP TO 13 HOURS) COULD HAVE BEEN CONTRIBUTING FACTORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304780 SHEARGUARD CHEST PAD COVERS COVERS KME MIZUHO ORTHOPEDIC SYSTEMS, INC. 5844-12

    Patients

    Seq Age Sex Outcome Treatment
    1 Other