BEUDAMED
    FDA Adverse Event Other Summary report: N

    DISPOSABLE FACE MASK (CASE OF 8)

    MDR report key: 727052 · Received June 19, 2006

    Report

    Report Number
    1643264-2006-00035
    Event Type
    Other
    Date Received
    June 19, 2006
    Date of Event
    May 15, 2006
    Report Date
    June 15, 2006
    Manufacturer
    SMITH & NEPHEW, INC. ENDOSCOPY DIVISION
    Product Code
    FXX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO

    Narratives

    Additional Manufacturer Narrative · 1

    SMITH & NEPHEW, INC. ENDOSCOPY DIV. IS SUBMITTED 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: PRODUCT IS NOT BEING RETURNED FOR EVALUATION THEREFORE, NO DETERMINATION COULD BE MADE FOR THE REPORTED INCIDENT. K-7663 06/15/2006

    Description of Event or Problem · 1

    USING THE BEACH CHAIR WITH FACE MASK ATTACHED, THE PT DEVELOPED ABRASIONS ON BOTH SIDES OF THE FACE FROM THE STRAPS. THIS WAS DISCOVERED AFTER THE SHOULDER CASE WAS COMPLETED. THE OR CHARGE NURSE STATED THE PT'S SKIN WAS BLEEDING FROM THE STRAPS THAT THE REP. ATTACHED. THE PT WAS TREATED WITH ANTIBIOTIC OINTMENT. THE SALES REP. STATED HE DIDN'T KNOW WHY THIS HAPPENED OTHER THAN THE STRAPS WERE POSSIBLY TIGHTENED BY THE ANESTHESIOLOGIST WHO WAS NOT FAMILIAR WITH THE PRODUCT AND THE PT WAS MOVED WHILE IN THE BEACH CHAIR. REP. INDICATED HE DID SEE THE ABRASIONS AND THE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE FACE MASK (CASE OF 8) NI FXX SMITH & NEPHEW, INC. ENDOSCOPY DIVISION 7210559

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other