BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACHOICE

    MDR report key: 2183169 · Received July 28, 2011

    Report

    Report Number
    2210968-2011-01026
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 15, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    MNB
    PMA / PMN Number
    P970021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A THERMAL ABLATION ON (B)(6) 2011. POSTOPERATIVELY THE PATIENT EXPERIENCED SEVERE CRAMPING AND AN ODOROUS YELLOW AND BEIGE DISCHARGE ON (B)(6) 011. THE PHYSICIAN DID NOT CALL BACK SO THE PATIENT TOOK A PERCOCET FOR THE CRAMPING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACHOICE CATHETER,BALLOON,TRANSCERVICAL MNB ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1