BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOT DOG PATIENT WARMING SYSTEM

    MDR report key: 4504229 · Received February 10, 2015

    Report

    Report Number
    3005857264-2015-00001
    Event Type
    Other
    Date Received
    February 10, 2015
    Date of Event
    December 9, 2014
    Report Date
    February 5, 2015
    Manufacturer
    AUGUSTINE BIOMEDICAL & DESIGN
    Product Code
    DWJ
    PMA / PMN Number
    K112488
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 12/09/2015, A (B)(6) DISTRIBUTOR ADVISED AUGUSTINE BIOMEDICAL AND DESIGN, LLC THAT A HOSPITAL MAY CALL TO REPORT AN INCIDENT. COMPANY REQUESTED HOSPITAL CONTACT AND SPOKE WITH HOSPITAL BIOMEDICAL ENGINEER WHO INDICATED THAT A WARMING BLANKET HAD FAILED WITH VISIBLE DAMAGE ALONG ONE SIDE; NO EVENT DETAIL OR PHOTOS OF BURN PROVIDED; LATER COMMUNICATED THAT THE EVENT HAD BEEN FORWARDED TO HOSPITAL RISK MANAGEMENT. COMPANY ISSUED HOSPITAL AND PRODUCT RETURN AUTHORIZATION TO RECEIVE AND EVALUATE THE PRODUCT. PRODUCT AND EVENT DETAIL WERE NOT RECEIVED AND COMPANY FOLLOWED UP WITH HOSPITAL ON 9 SEPARATE OCCASIONS, INCLUDING THE RETURN OF SEVERAL COMMUNICATIONS RELATED TO THE EVENT QUESTIONNAIRE TO AID EVENT INVESTIGATION AND POTENTIAL FILING. ON 01/09/2015, COMPANY REACHES HOSPITAL CLINICAL PERIOPERATIVE MANAGER WHO INFORMS COMPANY: A PATIENT INCURRED 2ND DEGREE BURN; PRODUCT WOULD NOT BE RETURNED AT THIS TIME; PRODUCT WOULD BE EVALUATED BY THIRD-PARTY AND A REPORT WOULD BE ISSUED; EVENT QUESTIONNAIRE WOULD BE ANSWERED. EVENT AWARENESS (CONFIRMATION OF INJURY) WAS DOCUMENTED AS 01/09/2015. COMPANY FOLLOW-UPS WITH HOSPITAL ADDITIONAL 3 TIMES FOR RESPONSE. ON 01/28/2015, COMPANY REACHES PERIOPERATIVE MANAGER WHO FURNISHES EVENT QUESTIONNAIRE; AT REQUEST OF COMPANY, DISTRIBUTOR FURNISHES PRODUCT PHOTOGRAPHS. AS OF 02/06/2015, NEITHER PRODUCT NOR THIRD-PARTY REPORT HAVE BEEN RECEIVED.

    Description of Event or Problem · 1

    PATIENT (MALE, (B)(6), UNKNOWN WEIGHT) UNDERWENT SURGERY TO REPAIR A LEFT INGUINAL HERNIA. SURGERY LASTED APPROXIMATELY 57 MINUTES. PATIENT WAS WARMED WITH HOT DOG PATIENT WARMING SYSTEM (B105 BLANKET). IN RECOVERY, PATIENT COMPLAINED OF RIGHT RIB CAGE/ABDOMEN PAIN. BURN WAS OBSERVED IN A NARROW AREA OF THE WARMING BLANKET USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99827 HOT DOG PATIENT WARMING SYSTEM B105 BLANKET DWJ AUGUSTINE BIOMEDICAL & DESIGN B105 1253

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other OPERATING ROOM ELECTRO-SURGICAL UNIT 15A| ESU PAD: RIGHT ANTERIOR THIGH| WC52 HOT DOG MULTI-PORT CONTROLLER SN (B)(4)| OPERATING ROOM SMOKE EVACUATION SYS01