BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DR. SCHOLL'S HEEL PAIN RELIEF ORTHOTICS-MEN'S

    MDR report key: 3899658 · Received May 22, 2014

    Report

    Report Number
    1031623-2014-00005
    Event Type
    Malfunction
    Date Received
    May 22, 2014
    Report Date
    May 12, 2014
    Product Code
    KNP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CASE DESCRIPTION: THIS SPONTANEOUS REPORT ORIGINATING FROM THE UNITED STATES AS RECEIVED FROM A CONSUMER REFERS TO A FEMALE PT OF UNK AGE. THIS REPORT CONCERNS 1 PT AND 1 DEVICE. THE PT USED THE ORTHOTIC ((B)(4) 'S HEEL PAIN RELIEF ORTHOTICS-MEN'S) FOR AN UNK INDICATION. ON AN UNK DATE THE PT EXPERIENCED 3 UNEXPECTED SURGERIES (MEDICALLY SIGNIFICANT) AND THE ORTHOTIC JUST DID NOT WORK FOR HER. THE ACTION TAKEN ON THE ORTHOTIC WAS UNK. THE OUTCOME OF THE 3 UNEXPECTED SURGERIES WAS REPORTED AS RECOVERING/RESOLVING. THE OUTCOME OF THE LACK OF EFFECT WAS UNK. THE REPORTER CONSIDERED THE LACK OF EFFECT TO BE RELATED TO ORTHOTIC ((B)(4)'S HEEL PAIN RELIEF ORTHOTICS-MEN'S), AND THE RELATEDNESS OF THE UNEXPECTED SURGERIES WAS UNK. THE ORTHOTIC ((B)(4)'S HEEL PAIN RELIEF ORTHOTICS-MEN'S) WAS NOT AVAILABLE FOR INVESTIGATION. FOR THE ORTHOTIC ((B)(4)'S HEEL PAIN RELIEF ORTHOTICS-MEN'S), THE LOT NUMBER WAS NOT AVAILABLE AND THE SERIAL NUMBER WAS NOT AVAILABLE. FOR THE ORTHOTIC ((B)(4)'S HEEL PAIN RELIEF ORTHOTICS-MEN'S), QUALITY INVESTIGATION STATUS: SINCE THE DEVICE WAS NOT BEING RETURNED AND NO BATCH OR LOT NO WAS AVAILABLE, EVALUATION FOR A MALFUNCTION WAS NOT POSSIBLE. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306502 DR. SCHOLL'S HEEL PAIN RELIEF ORTHOTICS-MEN'S ORTHOSIS, CORRECTIVE SHOE (KNP) KNP

    Patients

    Seq Age Sex Outcome Treatment
    1