BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WESTMED LLC

    MDR report key: 15942379 · Received December 8, 2022

    Report

    Report Number
    2028807-2022-00025
    Event Type
    Injury
    Date Received
    December 8, 2022
    Date of Event
    November 8, 2022
    Report Date
    December 9, 2022
    Manufacturer
    WESTMED LLC
    Product Code
    BYG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE TENDENCY FOR THE MASK TO SLIP WOULD BE DUE TO THE IMPROPER FIT OF THE PATIENT. THE CORNEAL ABRASIONS WOULD CAUSE PATIENT DISCOMFORT AND HAVE THE POTENTIAL FOR SERIOUS INJURY TO THE EYES. MASK WOULD NEED TO BE INVESTIGATED TO SEE WHICH AREAS ON THE MASK CAUSED THE CORNEAL ABRASIONS. BASED ON THIS INFORMATION THIS IS A REPORTABLE EVENT.

    Additional Manufacturer Narrative · 0

    THE TENDENCY FOR THE MASK TO SLIP WOULD BE DUE TO THE IMPROPER FIT OF THE PATIENT. THE CORNEAL ABRASIONS WOULD CAUSE PATIENT DISCOMFORT AND HAVE THE POTENTIAL FOR SERIOUS INJURY TO THE EYES. MASK WOULD NEED TO BE INVESTIGATED TO SEE WHICH AREAS ON THE MASK CAUSED THE CORNEAL ABRASIONS. BASED ON THIS INFORMATION THIS IS A REPORTABLE EVENT. COMPLAINT NOT CONFIRMED DUE TO LACK OF RETURN OR PHOTO. THERE WERE NO FG TO INSPECT, HOWEVER THE COMPONENTS OF THE PARTS WERE MEASURED AND ALL WERE WITHIN TOLERANCE. REQUESTED FOR THE NEXT PRODUCED LOT TO BE DIMENSIONALLY INSPECTED UPON MANUFACTURING. REVIEWED COMPLAINT HISTORY FOR THE PARTS AND PRODUCT FAMILY. THERE WERE NO COMPLAINTS FOR THOSE PARTS, AND NO SIMILAR REPORTED DEFECTS FOR THE PRODUCT FAMILY. RISK ANALYSIS INDICATED A SEVERITY OF 8, WITH POTENTIAL OF SERIOUS INJURY. THIS COMPLAINT WILL BE DISCUSSED AT THE NEXT CARB MEETING TO DETERMINE CAPA INITIATION. SCAR RESOLUTION SENT TO THE CUSTOMER.

    Description of Event or Problem · 0

    THE MASKS HAVE A TENDENCY TO SLIDE UP THE FACE WHEN THE PATIENTS MOVE AND ARE CAUSING CORNEAL ABRASIONS.

    Description of Event or Problem · 0

    THE MASKS HAVE A TENDENCY TO SLIDE UP THE FACE WHEN THE PATIENTS MOVE AND ARE CAUSING CORNEAL ABRASIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2260124 WESTMED LLC MEDIUM CONCENTRATION OXYGEN MASK ADULT W/7' TUBING BYG WESTMED LLC RSP1010A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other