BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP GWN W/KNITCF UNIV

    MDR report key: 19726607 · Received July 11, 2024

    Report

    Report Number
    9616096-2024-00003
    Event Type
    Injury
    Date Received
    July 11, 2024
    Date of Event
    June 13, 2024
    Report Date
    September 4, 2024
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    OEA
    UDI-DI
    30680651696008
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT AVAILABLE FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON THE CONCLUSION OF THE INVESTIGATION. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    A REVIEW OF DEVICE HISTORY RECORD WAS NOT ABLE TO BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED. BIOCOMPATIBILITY TESTING FOR THE BASE FABRIC AND OTHER COMPONENTS OF THE GOWN WITH DIRECT HUMAN CONTACT SHOWS THAT THE GOWN IS NON-SENSITIZING, NON-CYTOTOXIC, AND NON-IRRITATING TO POTENTIAL PATIENT AND END USERS. A REVIEW OF COMPLAINTS WAS PERFORMED AND THERE IS NO UPWARD TREND IN THE PAST 12 MONTHS FOR THIS ISSUE FOR THE COMPLAINT PRODUCT. NOTIFICATION WAS SENT TO MANUFACTURING LEADERS FOR AWARENESS PURPOSES. A ROOT CAUSE WAS NOT IDENTIFIED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED STRIKE THROUGH IN THE MIDDLE OF THE GOWN. THE GOWNS WERE USED FOR DECONTAMINATION, NOT FOR USE IN PATIENT CARE FOR THIS INCIDENT. AN EMPLOYEE HAD STRIKE THROUGH WHERE THE DETERGENT CAUSED A REACTION OF BURNING AND IRRITATION. EMPLOYEE WENT TO EMERGENCY DEPARTMENT AND WAS OUT OF WORK FOR 2 DAYS. EMPLOYEE UTILIZED AN OTC CREAM FOR IRRITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315925 IMP GWN W/KNITCF UNIV PROTECTIVE APPAREL OEA O&M HALYARD, INC. 69600 UNKNOWN 30680651696008

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other