BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGACLIP*MCA MED LONG APPLIER

    MDR report key: 17827207 · Received September 27, 2023

    Report

    Report Number
    3005075853-2023-06915
    Event Type
    Injury
    Date Received
    September 27, 2023
    Date of Event
    January 11, 2023
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDO
    UDI-DI
    10705036002482
    PMA / PMN Number
    K820837
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 9/27/2023. D4: BATCH # UNK. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: HAVE YOU BEEN PRESCRIBED MEDICATION BY A DOCTOR (NOT OVER THE COUNTER MEDICATION)? YES. IF YES, WHAT IS THE DOCTOR PRESCRIBED MEDICATION? LYRICA, INDOMETHACIN, MELOXICAM, PERCOSET / OXYCODONE, PREDNISONE. HAVE YOU HAD ANY DIAGNOSTIC TESTING DONE TO ADDRESS THE SYMPTOMS YOU EXPERIENCED? IF YES, WHAT DIAGNOSTIC TESTING WERE COMPLETED? MRI SOFT TISSUE NECK, CTA/CTV HEAD/NECK, EMG, ULTRASOUND NECK. WHAT ARE THE NEXT STEPS WHEN IT COMES TO THE PATIENTS CARE? TRIED STELLATE GANGLION NEVER BLOCK (DID NOT WORK). FURTHER TREATMENT IN PROCESS OF BEING DETERMINED." AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. HOWEVER, IF THE PRODUCT OR PRODUCT ID NUMBERS ARE RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT POST OP TO AN UNKNOWN PROCEDURE, THE PATIENT HAS PAIN AND INFLAMMATION IN THE NECK AND ON THE RIGHT SIDE 24/7 HAS TO TAKE PAIN MEDICATION FOR PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1096280 LIGACLIP*MCA MED LONG APPLIER CLIP, IMPLANTABLE GDO ETHICON ENDO-SURGERY, LLC. 10705036002482

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Disability