BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATTRESS COVER FOR THE HERCULES PATIENT REPOSITIONER

    MDR report key: 17789860 · Received September 21, 2023

    Report

    Report Number
    3010388769-2023-00001
    Event Type
    Injury
    Date Received
    September 21, 2023
    Date of Event
    August 25, 2023
    Report Date
    August 30, 2023
    Manufacturer
    THE MOREL COMPANY, LLC
    Product Code
    FNL
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MOREL COMPANY BELIEVES THE HERCULES MATTRESS HAS NOT CAUSED AN ALLERGIC REACTION WITH THIS PATIENT. AS REPORTED BY THE MEDICAL STAFF AT THE HOSPITAL PROVIDING THE CARE, THERE WERE NO CLINICALLY OUTWARD SIGNS OF AN ALLERGIC REACTION. THAT BEING SAID, EVERY EFFORT WILL BE TAKEN TO RETRIEVE THE MATTRESS COVER IN QUESTION AND TO ENSURE IT MEETS ALL BIOCOMPATIBILITY REQUIREMENTS.

    Description of Event or Problem · 0

    THE PATIENT ALLEGES THAT SHE WAS ALLERGIC TO THE MATTRESS COVER OF THE HERCULES PATIENT REPOSITIONER (HERCULES) AND THAT SHE COULD HAVE GONE INTO ANAPHYLAXIS SHOCK. THE PATIENT WAS CARED FOR AT ORLANDO HEALTH REGIONAL MEDICAL CENTER (OHMC) IN ORLANDO FLORIDA. A PRELIMINARY INVESTIGATION FOUND THAT THE MEDICAL STAFF AT OHMC REPORTED THAT THE PATIENT WAS ADMITTED TO OHMC COMPLAINING OF HALLUCINATIONS AND THAT SHE HAD MULTIPLE MENTAL HEALTH ISSUES (INCLUDING AN ANXIETY DISORDER) THAT PLAYED A ROLE DURING HER STAY. THE MEDICAL STAFF REPORTED THAT THERE WERE NO CLINICALLY OUTWARD SIGNS OF AN ALLERGIC REACTION AND THAT SHE HAD INTERACTED WITH SEVERAL LAYERS OF THEIR HOSPITAL MANAGEMENT DUE TO GENERAL DISCONTENT WITH HER HOSPITALIZATION STAY. THE HOSPITAL STAFF DIDN'T THINK THERE WAS ANY ADVERSE EVENT THAT NEEDED TO BE REPORTED. CONTACT INFORMATION AT OHMC IS: NURSE MANAGER: (B)(6). ASSISTANT NURSE MANAGER: (B)(6). ADDITIONAL COMMENTS: THE HERCULES MATTRESS COVER, WHICH IS PRODUCED BY SIOEN INDUSTRIES IN BELGIUM, LEVERAGES A HEALTHCARE TEXTILE FABRIC THAT HAS BEEN PROVEN TO BE SAFE AND EFFICACIOUS BY THE MOREL COMPANY AND OTHER MEDICAL DEVICE MANUFACTURERS. OTHER LARGE BED/MATTRESS MANUFACTURERS HAVE EITHER USED THIS FABRIC OR ARE CURRENTLY USING IT FOR A PORTION OF THEIR MATTRESS PRODUCTS. (B)(4), SIOEN'S TECHNICAL AND SALES REPRESENTATIVE TO THE MOREL COMPANY, REPORTS THAT IN HIS 30 YEARS OF WORKING WITH TRANSFER COATED POLYURETHANE (PU) FABRICS, INCLUDING BEING THE CEO AT THE INDUSTRY-LEADING DARTEX COATINGS, HE HAS NEVER HEARD OF ANY PU FABRIC CAUSING SKIN SENSITIVITY OR IRRITATION ISSUES. THE HERCULES PATIENT REPOSITIONER WAS COMMERCIALIZED IN 2013 AND THE FIRST UNITS WERE SOLD IN MARCH OF 2014. SINCE THEN, OVER (B)(4) SYSTEMS HAVE BEEN SOLD TO DATE RESULTING IN APPROXIMATELY (B)(4) PATIENT-DAYS. OVER THAT COURSE OF TIME, THERE HAVE BEEN NO OTHER CUSTOMER COMPLAINTS ALLEGING AN ALLERGIC REACTION TO THE HERCULES MATTRESS COVER. THE HERCULES MATTRESS COVER COMPLIES WITH THE ISO 10993 BIOCOMPATIBILITY INTERNATIONAL STANDARD FOR SKIN SENSITIZATION AND SKIN IRRITATION. DETAILED REPORTS ARE ON FILE AT THE MOREL COMPANY. ALSO, THE MATTRESS COVER CONTAINS NO LATEX OR SILICONE. THE ONGOING INVESTIGATION WILL INCLUDE THE EFFORT OF IDENTIFYING THE HERCULES MATTRESS COVER THAT THE PATIENT ALLEGES TO BE ALLERGIC TO, RETRIEVING THAT HERCULES MATTRESS COVER, AND VERIFYING THAT IT MEETS THE ISO 10993 BIOCOMPATIBILTY STANDARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1997443 MATTRESS COVER FOR THE HERCULES PATIENT REPOSITIONER PATIENT REPOSITIONER - PATIENT BOOST EQUIPMENT FNL THE MOREL COMPANY, LLC MCPB54 BUILD #149 2023

    Patients

    Seq Age Sex Outcome Treatment
    1 Female