BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICAL ORTHO U DRAPE 10

    MDR report key: 23017209 · Received September 10, 2025

    Report

    Report Number
    3005997949-2025-00006
    Event Type
    Injury
    Date Received
    September 10, 2025
    Date of Event
    August 22, 2025
    Report Date
    October 16, 2025
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    PUI
    UDI-DI
    30680651893476
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS UNAVAILABLE FOR RETURN AND SUBSEQUENT ANALYSIS. THE INVESTIGATION TEAM CONDUCTED A THOROUGH ANALYSIS OF THE PRODUCT COMPLAINT, FOCUSING ON IDENTIFYING THE ROOT CAUSE AND ASSESSING POTENTIAL RISKS. DESPITE LIMITED EVIDENCE, INCLUDING A SINGLE IMAGE WITHOUT ACCOMPANYING BATCH INFORMATION OR PHYSICAL SAMPLES, THE TEAM REVIEWED MANUFACTURING RECORDS, QUALITY CONTROL DATA, AND PRODUCT SPECIFICATIONS. THE DRAPE IN QUESTION UTILIZES SOLVENTUM TAPE, A DOUBLE-COATED ACRYLATE ADHESIVE ON POLYETHYLENE FILM WITH A SILICONE-TREATED PAPER LINER, PRODUCED IN A FACILITY COMPLIANT WITH FDA REGULATIONS AND CERTIFIED UNDER ISO 9001 AND 13485 STANDARDS. TOXICOLOGICAL AND CLINICAL EVALUATIONS CONFIRM THE PRODUCT'S SAFETY PROFILE, DEMONSTRATING IT TO BE NON-IRRITANT, NON-SENSITIZING, AND NON-CYTOTOXIC. THE INVESTIGATION FOUND NO DIRECT CORRELATION BETWEEN THE REPORTED ADVERSE REACTIONS AND THE PRODUCT'S FORMULATION OR MANUFACTURING PROCESS. OVERALL, THE PRODUCT MAINTAINS ITS COMPLIANCE WITH SAFETY AND QUALITY STANDARDS, AND NO MODIFICATIONS ARE WARRANTED AT THIS TIME. RESPONSES TO CUSTOMER QUESTIONNAIRE INDICATE THE PATIENT ALSO HAS A KNOWN ALLERGIC REACTION TO ADHESIVES AND DERMABOND. 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.

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THIS COMPLAINT IS NOT AVAILABLE FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON 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.

    Description of Event or Problem · 0

    A PATIENT EXPERIENCED AN ALLERGIC REACTION TO THE DRAPE RESULTING IN A RASH ON THE CHEST, BUTTOCKS, AND BOTH THE UPPER AND LOWER ABDOMEN. THE PATIENT SOUGHT MEDICAL TREATMENT WHICH INCLUDED ORAL STEROIDS AND A TOPICAL STEROID CREAM APPLIED FOR SEVERAL WEEKS. THE PATIENT IS KNOWN TO HAVE ALLERGIES TO ADHESIVE AND DERMABOND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2500830 SURGICAL ORTHO U DRAPE 10 SURGICAL DRAPES AND PACKS PUI O&M HALYARD, INC. 89347 UNKNOWN 30680651893476

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other