BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYH LAP DRAPE STERL

    MDR report key: 23818199 · Received December 16, 2025

    Report

    Report Number
    3005997949-2025-00014
    Event Type
    Malfunction
    Date Received
    December 16, 2025
    Date of Event
    November 12, 2025
    Report Date
    December 31, 2025
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    PUI
    UDI-DI
    10680651480504
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INCIDENT TWO. THE PRODUCT INVOLVED IN THE EVENT WAS NOT RETURNED FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE 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 PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    BASED ON THE RESULTS OF THE INVESTIGATION, THE ISSUE WAS CONFIRMED FROM THE PHOTO PROVIDED. THE IMAGE INDICATES INSUFFICIENT ADHESIVE IN THE LEGGING COMPONENT. HOWEVER, BECAUSE NO SAMPLE WAS RETURNED, IT COULD NOT BE DETERMINED WHETHER THE ADHESIVE WAS MISSING ENTIRELY OR IMPROPERLY APPLIED. A REVIEW OF THE DRAPE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT MET ALL MANUFACTURING PROCESS AND QUALITY REQUIREMENTS PRIOR TO RELEASE, AND NO REWORK OR SPECIAL CONDITIONS WERE REPORTED. CLEANING RECORDS ASSOCIATED WITH THE MANUFACTURING PROCESS WERE REVIEWED WITH NO ISSUES IDENTIFIED. A VISUAL INSPECTION OF THE CURRENT WAREHOUSE INVENTORY FOR THE AFFECTED COMPONENT ALSO REVEALED NO ABNORMALITIES. ALL QUALITY INSPECTIONS HAD BEEN COMPLETED IN ACCORDANCE WITH PROCEDURES. FL70104 LINE¿S PERSONNEL WERE RETRAINED IN JOB AID JA-07688 GLUING GENERIC INSTRUCTION TO REINFORCE GOOD MANUFACTURING PRACTICES AND AVOID RECURRENCE ON THIS ISSUE. PERSONNEL OF THE MANUFACTURING LINE WERE NOTIFIED OF THE INCIDENT FOR HEIGHTENED AWARENESS. THE COMPLAINT HAS BEEN LOGGED IN THE TRACKING AND TRENDING PROGRAM TO MONITOR FOR ANY EMERGING TRENDS. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE 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 PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN ISSUE WITH THE ROBOTIC DRAPE WITH ATTACHED LEGGINGS, NOTING THAT THE SEAMS ON THE LEGGINGS ARE COMING APART. CUSTOMER REPORTED NO PATIENT INJURY OR MEDICAL TREATMENT WAS REQUIRED. ADDITIONAL INFORMATION WAS REQUESTED ON (B)(6) 2025, (B)(6) 2025, AND (B)(6) 2025. NO RESPONSES HAVE BEEN RECEIVED TO-DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2205935 HYH LAP DRAPE STERL HYH LAP DRAPE STERL PUI O&M HALYARD, INC. 48050 UNKNOWN 10680651480504

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown