BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP GWN W-KNITCF UNIV

    MDR report key: 18895839 · Received March 13, 2024

    Report

    Report Number
    9616096-2024-00002
    Event Type
    Injury
    Date Received
    March 13, 2024
    Report Date
    May 7, 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
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. A QUALITY NONCONFORMANCE WAS NOT REPORTED DURING LOT MANUFACTURE. VISUAL AND FUNCTIONAL INSPECTIONS ARE PERFORMED FOR EACH LOT BASED ON STATISTICAL SAMPLING. COMPLAINT TREND WAS REVIEWED FOR CODE 69600 FOR STRIKE THROUGH FAILURE MODE. THERE IS NO UPWARD TREND DETECTED DURING THE PAST 12 MONTHS. A ROOT CAUSE WAS NOT IDENTIFIED. NOTIFICATION OF THIS INCIDENT WAS SENT TO MANUFACTURING LEADERS FOR AWARENESS. 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. H3 OTHER TEXT: DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THIS COMPLAINT IS 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 A O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    CUSTOMER IS DISSATISFIED WITH GOWN PERFORMANCE. CUSTOMER STATES THEY HAVE USED GOWN FOR 15 YEARS AND QUALITY HAS DECREASED. CUSTOMER STATES THE GOWN BECOMES WET WHEN SHE LEANS AGAINST SINK. THE CUSTOMER REPORTED IN 2018 A CO-WORKER EXPERIENCED CHEMICAL BURNS ON THEIR ARMS DURING USE OF THE GOWN WHEN ENZYMATIC FLUID SOAKED THROUGH THE GOWN. THE CO-WORKER WENT TO THE PHYSICIAN MULTIPLE TIMES FOR TREATMENT. THE EXACT EVENT DATE AND FURTHER DETAILS ARE UNKNOWN. THERE WAS NO HOSPITAL STAY OR SURGICAL INTERVENTION PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1178387 IMP GWN W-KNITCF UNIV PROTECTIVE APPAREL OEA O&M HALYARD, INC. 69600 AM23292921 30680651696008

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other