BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DVT CALF GARMENTS STANDARD

    MDR report key: 3080625 · Received April 4, 2013

    Report

    Report Number
    3007420694-2013-00018
    Event Type
    Injury
    Date Received
    April 4, 2013
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. ZO.O.
    Product Code
    JOW
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH, INC ON BEHALF OF THE MFR (ARJOHUNTLEIGH (B)(4)). BASED ON THE INFO RECEIVED FROM OUR SSU (SALES AND SERVICE UNIT) ON DISCUSSIONS WITH THE FACILITY, IT HAS BEEN DETERMINED THAT THE INCORRECT SIZE OF GARMENT WAS USED AND CONTRIBUTED TO PT'S CONDITION. INFO IN OUR IFU (507900US) PROVIDES USERS WITH HOW TO SET UP THE SYSTEM, GARMENT APPLICATION AND GENERAL GUIDELINES AND RECOMMENDATIONS IN ORDER TO ENSURE SUITABILITY. THE FACILITY HAS AGREED AND WE (ARJOHUNTLEIGH) SUPPORT THEM IN EDUCATING THEIR STAFF MEMBERS ON THE APPLICATION AND SIZES OF DIFFERENT GARMENTS VIA IN-SERVICING. BASED ON OUR PMS (POST MARKET SURVEILLANCE) DATA, THIS IS NOT A TYPICAL OR COMMON EVENT, BUT MORE OF AN ISOLATED EVENT, WITH THE MAJORITY OF FACILITIES FOLLOWING OUR RECOMMENDATIONS LISTED IN THE IFU. OVER THE PAST FIVE YEARS, THERE HAS NOT BEEN A CASE REPORTED TO US (MFR) WHERE THE INCORRECT SIZE OF GARMENT HAS CONTRIBUTED TO A PT INJURY. LAST YEAR, WE DID REPORT THREE SIMILAR INCIDENTS WHEREBY INJURY WAS SUSTAINED, HOWEVER, THE ROOT CAUSE WAS NOT LINKED TO THE FUNCTION OR FITMENT OF THE GARMENT AND MORE RELATED TO THE PT'S MEDICAL CONDITION (REF: 3005619970-2012-00010, 3005619970-2012-00011 AND 3005619970-2012-00012). WE WILL CONTINUE TO MONITOR INCIDENTS OF THIS NATURE IN ADDITION TO MAINTAINING AND SUPPORTING OUR CUSTOMER'S NEEDS IN REGARDS TO ANY IN-SERVICE TRAINING REQUIREMENTS, HOWEVER, IN RELATION TO THIS INCIDENT, WE DO NOT SEE THAT OUR DEVICE FAILED TO FUNCTION OR CAUSED THE INJURY TO OCCUR. ON THE INFO SUPPLIED BY THE FACILITY (WOODLAND HILLS MEDICAL CENTER), THE PT SUFFERED FROM SWELLING AND REDNESS OF THE LIMB. WE ARE UNAWARE OF THE OUTCOME OF THE INJURY. WE WILL BE RETURNING TO THE FACILITY NEXT WEEK TO PROVIDE EDUCATION ON THE APPLICATION AND SIZES OF THE DIFFERENT GARMENTS VIA INSERVICING.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139534 DVT CALF GARMENTS STANDARD DVT JOW ARJOHUNTLEIGH POLSKA SP. ZO.O.

    Patients

    Seq Age Sex Outcome Treatment
    1