BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOPHONO®

    MDR report key: 5922367 · Received September 1, 2016

    Report

    Report Number
    1045254-2016-00284
    Event Type
    Injury
    Date Received
    September 1, 2016
    Report Date
    August 11, 2016
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    LXB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: ANALYSIS RESULTS NOT AVAILABLE; DEVICE NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THIS FILE WILL INVESTIGATE THE INFORMATION PUBLISHED IN THE RESEARCH ARTICLE ¿MEDICINAL HONEY FOR BAHI SKIN REACTIONS¿, FAUCETT, ET AL; LARYNGOSCOPE 125: JULY 2015. ¿BONE-ANCHORED HEARING IMPLANTS (BAHIS) ARE SURGICALLY IMPLANTABLE SYSTEMS.¿ THE OBJECTIVE OF THIS ARTICLE ¿EVALUATES THE USE OF MEDIHONEY IN PATIENTS WHO DEVELOPED SKIN REACTIONS AT THEIR SURGICAL SITE FOLLOWING BAHI SURGERY PERFORMED AT A SINGLE INSTITUTION.¿ ¿BETWEEN 2011 AND 2014, 32 BAHIS WERE SURGICALLY IMPLANTED FOR 31 PATIENTS MEETING APPROPRIATE INDICATIONS. SOPHONO (SOPHONO INC., BOULDER, CO) (N=6).¿ ¿OF THE 32 BAHI CASES, SEVEN IMPLANTS DEVELOPED SKIN REACTIONS OF SOME KIND AND WERE GRADED ON THE HOLGERS CLASSIFICATION SYSTEM.¿ HOLGERS CLASSIFICATION: GRADE 0: REACTION-FREE SKIN AROUND THE ABUTMENT INCIDENCE: 90%¿95% GRADE 1: REDNESS WITH SLIGHT SWELLING AROUND THE ABUTMENT INCIDENCE: 3%¿5% GRADE 2: REDNESS, MOISTNESS, AND MODERATE SWELLING INCIDENCE: 1%¿4% GRADE 3: REDNESS, MOISTNESS, AND MODERATE SWELLING WITH TISSUE GRANULATION AROUND THE ABUTMENT INCIDENCE: 0.5%¿1.5% GRADE 4: OVERT SIGNS OF INFECTION RESULTING IN REMOVAL OF THE IMPLANT INCIDENCE: <(><<)>0.5% * TABLE I. ONE OF THE SOPHONO PATIENTS DEVELOPED A SKIN REACTION THAT WAS GRADED A ¿3¿ ON THE HOLGERS CLASSIFICATION. THE PATIENT REQUIRED MEDICAL INTERVENTION OF AUGMENTIN AND A DOUBLE ANTIBIOTIC OINTMENT, AND THEIR ISSUE RESOLVED WITHIN 4 WEEKS. ¿FOUR OF THE PATIENTS WERE PRESCRIBED MEDIHONEY, WHEREAS THE OTHER THREE WERE GIVEN EITHER TOPICAL AND/OR ORAL ANTIBIOTICS. OF NOTE, MEDIHONEY WAS UTILIZED IN PATIENTS OPERATED LATER IN THE TIMELINE, AS THE AUTHORS WERE UNAWARE OF THIS PRODUCT PREVIOUSLY. PATIENTS WERE TYPICALLY INSTRUCTED TO USE A SMALL AMOUNT OF MEDIHONEY CREAM OR TOPICAL ANTIBIOTICS THREE TIMES DAILY FOR 10 TO 14 DAYS. NO WEIGHT BASED DOSING IS REQUIRED. ALL PATIENTS USING MEDIHONEY HEALED IN <(><<)>2 WEEKS, WHEREAS THOSE USING OTHER METHODS INCLUDING ORAL ANTIBIOTIC AND/OR TOPICAL ANTIBIOTIC HEALED AT AN AVERAGE OF 5.25 WEEKS. NO PATIENTS REQUIRED REVISION SURGERY.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572721 SOPHONO® HEARING AID, BONE CONDUCTION LXB MEDTRONIC XOMED INC. UNKNOWN SOPHIMPL

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention