BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HALYARD BREAST DRAPE 100 IN 76 IN 124 IN

    MDR report key: 25280250 · Received May 26, 2026

    Report

    Report Number
    3014421917-2026-00013
    Event Type
    Injury
    Date Received
    May 26, 2026
    Date of Event
    April 29, 2026
    Report Date
    May 26, 2026
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    PUI
    UDI-DI
    30680651892363
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    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 BREAST DRAPE. THE COMPLAINT HALYARD BREAST DRAPE, PART NUMBER 89236 IS CONTRACT MANUFACTURED BY LIANYUNGANG AIYEH NON-WOVEN PRODUCTS CO., LTD (FDA REGISTRATION NUMBER 3004713352). SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS SUBMITTED TO THE MANUFACTURER ON MAY 6, 2026. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION AND RESPONSE BY THE 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

    DURING THE PROCEDURE, LINT FELL INTO SURGICAL SITE. THE PHYSICIAN REMOVED THE LINT FROM THE PATIENT¿S WOUND USING FORCEPS. NO PATIENT INJURY WAS REPORTED, ONLY BRIEF INTERRUPTION TO EXTRACT LINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126578 HALYARD BREAST DRAPE 100 IN 76 IN 124 IN SURGICAL DRAPES AND PACKS PUI O&M HALYARD, INC. 89236 CA25300XXX 30680651892363

    Patients

    Seq Age Sex Outcome Treatment
    1