BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U-P REUS H/C 5X10.5 BULK 12/CA

    MDR report key: 2231084 · Received July 20, 2011

    Report

    Report Number
    2183164-2011-00002
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Report Date
    July 14, 2011
    Manufacturer
    COVIDIEN
    Product Code
    IMD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2011. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2011 THAT A CUSTOMER HAD AN ISSUE WITH A HOT/COLD PACK. THE PT'S HUSBAND STATED THE GEL FROM THE PACK LEAKED FROM THE TOP SEAM, CAUSING 2ND DEGREE CHEMICAL BURNS ON HER BACK IN TWO DIFFERENT AREAS. THE PT WAS INITIALLY SEEN AT THE EMERGENCY ROOM AND WAS TREATED WITH SILVADENE DRESSINGS AND PAIN MEDICATION. THE PT WAS THEN SEEN BY HER PRIMARY CARE PHYSICIAN, DR. (B)(6), IN HIS OFFICE. AT THAT TIME THE DOCTOR REMOVED THE DEAD SKIN FROM HER WOUNDS AND PRESCRIBED PAIN MEDICATION TO ELIMINATE PAIN IN THE NERVE ENDINGS. THE PT WAS SEEN FOR A F/U VISIT WITH DR. (B)(6), AND THE PT'S HUSBAND REPORTS THAT HIS WIFE'S BURNS ARE HEALING, AND SHE CONTINUES TO TAKE THE PAIN MEDICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U-P REUS H/C 5X10.5 BULK 12/CA HOT / COLD PACK IMD COVIDIEN MH73912 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK