BEUDAMED
    FDA Adverse Event Summary report: N

    BAIR HUGGER

    MDR report key: 1171568 · Received September 11, 2008

    Report

    Report Number
    1171568
    Date Received
    September 11, 2008
    Date of Event
    August 13, 2008
    Report Date
    September 8, 2008
    Manufacturer
    ARIZANT HEALTHCARE, INC.
    Product Code
    DWJ
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PRE-OP PREP: BUTTOCKS/BACK BILATERAL; POVIDINE SOLUTION/SCRUB/HAIR REMOVAL-CLIPPED. DRAPING: WITH FOUR CLOTH TOWELS (PLACED DIRECTLY ON THE PATIENT'S BACK) AROUND THE PERIMETER OF THE INCISION, ANTIMICROBIAL DRAPE ADHERED TO INCISION WOUND EDGES, AND DRAPE. BODY POSITION: PRONE. IN THE A.M. OF THE FIRST POST-OP DAY, THE PATIENT COMPLAINED OF A MODERATE PAIN/BURNING SENSATION TO LOWER BACK NOT RELIEVED BY PAIN MEDS. THE NURSE EXAMINED THE INCISION DRESSING AND NOTED A REDDENED/BROWNISH AREA LOCATED DIRECTLY ABOVE THE DRESSING. THIS AREA WAS DESCRIBED AS BEING HARD AND SLIGHTLY RAISED WITH TWO BLISTERS. THE PRIMARY CARE PHYSICIAN EXAMINED THE AREA AND INDICATED IT HAD THE APPEARANCE OF A CONTACT DERMATITIS VS. LOCALIZED HEMATOMA. THE SURGEON EXAMINED THE AREA AND NOTED A LARGE BUT DISCRETE AREA OF ERYTHEMA, INDURATION AND BLISTERING ROSTRAL BUT ADJACENT TO THE UPPER PART OF THE INCISION. THE INCISION ITSELF APPEARS NORMAL. THE SURGEON QUESTIONED THE ETIOLOGY--THE SURGERY WAS ROUTINE AND THIS SITE APPEARED NORMAL WHEN THE DRESSING WAS APPLIED AT THE END OF THE CASE. (SURGERY STAFF ALSO CONCURRED THAT THIS SITE WAS NORMAL APPEARING IMMEDIATELY AFTER THE SURGERY.) THE BIPOLAR AND CAUTERY WERE APPROPRIATELY GROUNDED AND THERE WAS NO DIRECT CONTACT WITH METAL TO THE SKIN IN THAT AREA. THERE WAS NO DISRUPTION OF CURRENT DURING THE PROCEDURE. THE AREA IS DRAPED OUTSIDE THE SURGICAL FIELD. THERE WAS NO BURN/SINGE TO ANY DRAPING. A PLASTIC SURGEON INDICATED THAT THE AREA CLINICALLY RESEMBLES A BURN (THERMAL); BUT DID NOT BELIEVE THAT DIRECT CAUTERY OR CAUTERY PAD CAUSED THE BURN. OTHER CONSIDERATIONS INCLUDED: CHEMICAL BURN FROM PREP IF ALLOWED TO POOL (STAFF STATED PREP WAS NOT ALLOWED TO POOL) AND CONTACT REACTION (ADHESIVE OF DRAPE CAN CAUSE SOME SHEARING FORCES). THE WOUND WAS DESCRIBED HAVING SOME PARTIAL THICKNESS/SUPERFICIAL WOUNDS AS WELL AS SOME BULLAE. IT COVERS AN AREA OF ABOUT 11 X 11 CM. IT WAS NOT CONFLUENT, THERE WAS NO SURROUNDING ERYTHEMA. THE ANESTHESIOLOGIST EXAMINED THE WOUND AND REPORTED THERE WAS NO EVIDENCE OF SKIN IRRITATION OR BURN IN THE AREA THAT WAS COVERED BY THE BAIR HUGGER. A WOUND SPECIALIST EXAMINED A PHOTO AND POINTED OUT BRUISING UNDER THE SKIN THAT APPEARS TO BE SHAPED LIKE AN OUTLINE. BRUISING CAN RESULT FROM PRESSURE FROM AN INSTRUMENT, FOR EXAMPLE. SURGERY STAFF CLARIFIED THERE WAS NO SOURCE OF PRESSURE TO THIS SITE DURING THE PROCEDURE. THERE WERE LAYERS OF DRAPES BETWEEN THE INSTRUMENTS AND THE SITE (NO INSTRUMENT WERE AGAINST THE PATIENT'S SKIN). THE INSTRUMENT USED CLOSEST TO THE AREA OF THE WOUND WAS A RETRACTOR. SURGERY STAFF STATED THAT THE MICROSCOPE USED HAS A LIGHT (HEAT) SOURCE, BUT WOULD NOT HAVE BEEN POSITIONED NEAR THE AREA WHERE THE WOUND APPEARED. BIOMED EXAMINED THE CAUTERY AND THE CAUTERY PASSED OPERATIONAL TESTING. THE DISPOSABLES WERE NOT RETAINED. PATIENT TO FOLLOW UP WITH PLASTIC SURGEON AFTER DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAIR HUGGER WARMING DEVICE DWJ ARIZANT HEALTHCARE, INC. 522 *
    2 VALLEYLAB ADULT REM POLYHESIVE II PATIENT RETURN ELECTRODE ELECTRODE, ESU, DISPERSIVE ODR COVIDIEN VALLEYLAB * *
    3 VALLEYLAB FORCE FX ESU GEI COVIDIEN VALLEYLAB * *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR