BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTANT WARM PACK LARGE 6X9IN SODIUM ACETATE SINGLE PT USE

    MDR report key: 22136584 · Received June 3, 2025

    Report

    Report Number
    3003753847-2025-00013
    Event Type
    Injury
    Date Received
    June 3, 2025
    Report Date
    June 12, 2025
    Manufacturer
    OWENS & MINOR DISTRIBUTION, INC.
    Product Code
    IMD
    UDI-DI
    10885632413735
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INCIDENT TWO THE PRODUCT INVOLVED IN THIS EVENT IS NOT AVAILABLE FOR EVALUATION. OWENS & MINOR DISTRIBUTION, INC. IS THE INITIAL IMPORTER AND DISTRIBUTOR OF THE MEDICAL DEVICE. THE PRODUCT IS MANUFACTURED BY RAPID AID CORPORATION, (FDA REGISTRATION NUMBER 9710505). A SCAR (SUPPLIER CORRECTIVE ACTION REQUEST) WAS ISSUED ON MAY 20, 2025. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT COMP(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

    INCIDENT TWO: NO LOT NUMBER WAS PROVIDED BY COMPLAINT REPORTER. TWO RECENT LOT RETAINED SAMPLES WERE EVALUATED. THE SAMPLES WERE FOUND TO MEET TEMPERATURE AND PRESSURE TEST SPECIFICATIONS. THERE WAS NO EVIDENCE OF LEAKAGE DURING PRODUCT ACTIVATION AND PRESSURE TEST. A DEVICE HISTORY RECORD REVIEW ON THE COMPLAINT PRODUCT WAS UNABLE TO BE CONDUCTED DUE TO LACK OF LOT NUMBER. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR LAST THREE LOTS, NO MANUFACTURING PROCESS ISSUES WERE DETECTED. ONE SIMILAR COMPLAINT WAS RECEIVED FOR THE PRODUCT WITHIN THE LAST 12 MONTHS. THE INCIDENT WAS DETERMINED TO BE ISOLATED BASED ON TRACKING AND TRENDING DATA AND IN CONSIDERATION OF EVALUATION OF RETAINED SAMPLES AND RECENT DEVICE HISTORY RECORD REVIEW DEMONSTRATING NO REPEAT OF 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.

    Description of Event or Problem · 0

    THE NURSE REPORTED HEAT PACK EXPLODED OVER MOM AND BABY. SHE STATED THAT SHE WENT INTO THE ROOM AND IMMEDIATELY GRABBED THE BABY TO WASH HIM OFF BECAUSE HE WAS COVERED IN THE CONTENTS FROM THE HEAT PACK. THE PATIENT STATED SHE FELT LIKE HER FACE WAS BURNING AS THE CONTENTS GOT INTO HER LEFT EYE. THE NURSE IMMEDIATELY WASHED OUT THE MOM'S EYES. THE NURSE STATED SHE WANTED TO GET THE BABY CLEANED UP QUICKLY AND GET MOM ASSESSED BY HER OB DOCTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876133 INSTANT WARM PACK LARGE 6X9IN SODIUM ACETATE SINGLE PT USE PACK, HOT OR COLD, DISPOSABLE IMD OWENS & MINOR DISTRIBUTION, INC. 51775 2408RA75V4 10885632413735

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other