BEUDAMED
    FDA Adverse Event Other Summary report: N

    VULCAN GENERATOR

    MDR report key: 727051 · Received June 19, 2006

    Report

    Report Number
    1643264-2006-00036
    Event Type
    Other
    Date Received
    June 19, 2006
    Date of Event
    May 19, 2006
    Report Date
    June 16, 2006
    Manufacturer
    SMITH & NEPHEW, INC. ENDOSCOPY DIV.
    Product Code
    HRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    SMITH & NEPHEW, INC. ENDOSCOPY DIV. IS SUBMITTING THE ENCLOSED REPORT TO COMPLY WITH 21 CFR 803, THE MDR REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY SMITH & NEPHEW INC. ENDOSCOPY DIV., WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE OF THE REPORT WHICH WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, INC. ENDOSCOPY DIV, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, SMITH & NEPHEW, INC. ENDOSCOPY DIV. OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, INC. ENDOSCOPY DIV. OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. H10: THE UNIT HAS NOT BEEN RETURNED FOR EVALUATION THEREFORE, NO DETERMINATION COULD BE MADE FOR THE REPORTED INCIDENT. K-7673 06/16/2006.

    Description of Event or Problem · 1

    PAD BURN WAS REPORTED. OR NURSE STATED THAT THE PT WAS FOLLOWED-UP WITHIN 24HRS, 48HRS AND A DAY AFTER THAT AND THE PT WAS UNABLE TO SEE THE SUSPECT PAD BURN. THEY ARE NOW CALLING IT A REACTION TO THE ADHESIVE OR IRRITATION FROM THE ADHESIVE. THE CUSTOMER WAS USING THE VALLEY LEB PAD, NON-SPLIT, AND NOW HAVE GONE TO THE CONMED PADS. PAD WAS PLACED ON THE THIGH, THE PT WAS HEAVY AND VOIDED, WHICH COULD HAVE GOTTEN THE PAD WET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VULCAN GENERATOR GENERATOR HRX SMITH & NEPHEW, INC. ENDOSCOPY DIV. 7209673

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other