BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALYARD SHOULDER ARTHROSCOPY DRAPE

    MDR report key: 24798254 · Received April 7, 2026

    Report

    Report Number
    3014421917-2026-00005
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Report Date
    April 22, 2026
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    PUI
    UDI-DI
    30680651890703
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE EVENT IS NOT AVAILABLE FOR EVALUATION. O&M HALYARD, INC. IS THE SPECIFICATION DEVELOPER AND COMPLAINT HANDLING ESTABLISHMENT OF THE HALYARD SHOULDER ARTHROSCOPY DRAPE. THE COMPLAINT COMPONENT HALYARD SHOULDER ARTHROSCOPY DRAPE, PART NUMBER 89070 IS CONTRACT MANUFACTURED BY (B)(4) (FDA REGISTRATION NUMBER (B)(4)). SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS SUBMITTED TO THE MANUFACTURER ON MARCH 23, 2026. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION AND RESPONSE BY THE CONTRACT MANUFACTURER. 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 DRAPE FABRIC TORE DURING THE PROCEDURE; HOWEVER, NO INJURY WAS REPORTED. THE CUSTOMER INDICATED THE SURGEON APPLIED ADHESIVE TAPE TO THE TEAR AND PROCEEDED WITH THE OPERATION. THE DAMAGED PORTION OF THE DRAPE DID NOT COME INTO CONTACT WITH THE SURGICAL SITE, AND NO DELAY IN THE PROCEDURE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857568 HALYARD SHOULDER ARTHROSCOPY DRAPE SURGICAL DRAPES AND PACKS PUI O&M HALYARD, INC. 89070 CA25352XXX 30680651890703

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown