BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDICHOICE SKIN PREP PAD

    MDR report key: 22512665 · Received July 15, 2025

    Report

    Report Number
    3014421917-2025-00035
    Event Type
    Injury
    Date Received
    July 15, 2025
    Date of Event
    June 24, 2025
    Report Date
    September 8, 2025
    Manufacturer
    OWENS & MINOR DISTRIBUTION, INC.
    Product Code
    NEC
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLES AVAILABLE; THE PHOTOGRAPH CONFIRMS THE REACTION TO THE (B)(4) COMPONENT. THE SUPPLIER (B)(4) REVIEWED CLEANING AND MAINTENANCE RECORDS OF THE EQUIPMENT USED IN THE PRODUCTION OF THIS LOT. THE CLEANING AND MAINTENANCE WERE CARRIED OUT AS REQUIRED. PER SUPPLIER, THE CHEMICAL RAW MATERIALS AND PACKAGING MATERIALS USED IN THE SKIN PREP ARE SOURCED FROM QUALIFIED SUPPLIERS AND WERE ALL SUBJECTED TO SAMPLE INSPECTIONS BEFORE STORAGE. VISUAL AND MICROBIAL INSPECTIONS PASSED. THE SUPPLIER TESTED (B)(4) (LOT 2410JK510A) WITH CHLORAPREP PRODUCT BY CONDUCTING A HUMAN SKIN PATCH TEST. AFTER APPLYING CHLORAPREP PER IFU, (B)(4) WAS PLACED ON THE SKIN FOR 48 HOURS. NO ADVERSE REACTION OCCURRED. THE SUPPLIER PROVIDED RECORDS OF SKIN IRRITATION TESTING CONDUCTED BY A QUALIFIED THIRD-PARTY TEST LAB ON PRODUCT. THE RESULTS INDICATE THE RESPONSE AREA OF SKIN TESTED DID NOT EXCEED THE CONTROL. THERE WAS NEGLIGIBLE RESPONSE. THE ROOT CAUSE OF COMPLAINT REMAINS UNKNOWN. A COMPLAINT TRENDING ANALYSIS CONFIRMS NO POSITIVE TREND FOR THIS ISSUE. 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 HAS CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE EVENT WAS NOT RETURNED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION. OWENS AND MINOR DISTRIBUTION INC. WAS THE INITIAL IMPORTER FOR THE COMPLAINT PRODUCT. OWENS & MINOR DISTRIBUTION INC. FURL IMPORT ACCOUNT HAS SINCE BEEN DISABLED AND IMPORT PERFORMED AND TRANSFERRED TO O&M HALYARD INC. REGISTRATION 3014421917. MEDICHOICE SKIN PROTECTANT PREP PAD COMPONENT, R6384, LOT 2410JK510A, IS MANUFACTURED BY JIANERKANG MEDICAL CO. LTD. (FDA REGISTRATION 9616874). A SUPPLIER CORRECTIVE ACTION REQUEST HAS BEEN SENT TO MANUFACTURER. 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 HAS CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT HAD A REACTION (DESCRIBED AS BURN) FOLLOWING USE OF MEDICHOICE SKIN PREP PAD, R6384, LOT 2410JK510A. PATIENT IS BEING MONITORED FOR ANY SIGNS OF INFECTION. NO OTHER TREATMENT OR PATIENT EFFECTS WERE COMMUNICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545043 MEDICHOICE SKIN PREP PAD MEDICHOICE SKIN PREP PAD NEC OWENS & MINOR DISTRIBUTION, INC. R6384 2410JK510A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other