BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULATED REUS GEL PK M 4.5X10.5IN

    MDR report key: 17347427 · Received July 18, 2023

    Report

    Report Number
    1423537-2023-00963
    Event Type
    Malfunction
    Date Received
    July 18, 2023
    Date of Event
    May 26, 2023
    Report Date
    September 29, 2023
    Manufacturer
    MO016 MO-MOBERLY
    Product Code
    IMD
    UDI-DI
    00192253061362
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS FORWARDED TO THE MANUFACTURING FACILITY WHERE IT IS CURRENTLY STILL UNDER INVESTIGATION. A FOLLOW UP REPORT WILL BE FILED ONCE THE RESULTS HAVE BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    AS NO SAMPLES WERE RETURNED FOR EVALUATION, A ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT WAS NOT PROVIDED. CARDINAL HEALTH HAS MADE A BUSINESS DECISION TO CLOSE THE SITE WHICH MANUFACTURES PRODUCT 80304A AND TRANSITION TO A THIRD-PARTY MANUFACTURER. CARDINAL HEALTH WILL CONTINUE TO MONITOR COMPLAINT TRENDS FOR THIS REPORTED ISSUE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED PATIENT HAD TOTAL ABDOMINAL HYSTERECTOMY (HAD BLOCK W/ MARCAINE & EXPAREL PRE-OP). A HEAT PACK WAS USED POST-OP FOR CRAMPING & ABDOMINAL PAIN. NURSING REPORTED HEATING PACK WAS USED PER MANUFACTURER GUIDELINES AND PLACED ABOVE THE BINDER. A SMALL BLISTERED AREA NOTED AT INCISION WITH SURROUNDING ERYTHEMA. PATIENT RETURNED TO HOSPITAL WITH CONCERN FOR BURN AT INCISION SITE AND INFECTION. SHE REQUIRED ADMISSION, PLASTIC SURGERY CONSULT, AND 2 ADDITIONAL PROCEDURES WITH XENOGRAFT PLACEMENT. PATIENT DID REPORT SHE USED HEAT ON HER ABDOMEN AFTER DISCHARGE- UNABLE TO DETERMINE TYPE OF HEATING PACK USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37329 INSULATED REUS GEL PK M 4.5X10.5IN PACK, HOT OR COLD, DISPOSABLE IMD MO016 MO-MOBERLY 80304A UNKNOWN 00192253061362

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H