BEUDAMED
    FDA Adverse Event Other Summary report: N

    DR SCHOLL'S PAIN RELIEF ORTHOTICS (PRO) FOR ARCH

    MDR report key: 4184040 · Received October 15, 2014

    Report

    Report Number
    1031623-2014-00011
    Event Type
    Other
    Date Received
    October 15, 2014
    Report Date
    October 6, 2014
    Product Code
    KNP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    POST CONCUSSION SYNDROME (POST CONCUSSION SYNDROME), LOSS OF BALANCE (EQUILIBRIUM LOSS), SPRAINS (SPRAIN), GREAT DEAL OF PAIN (PAIN), HEADACHES (HEADACHE), ACCIDENT (ACCIDENT), NOT HELPFUL TO ME (THERAPEUTIC PRODUCT INEFFECTIVE). (B)(4).

    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 (DR (B)(6)S PAIN RELIEF ORTHOTICS (PRO) FOR ARCH, WOMENS) FOR AN UNK INDICATION. NO OTHER CO-SUSPECTS WERE REPORTED. NO CONCOMITANT MEDICATIONS WERE REPORTED. ON AN UNK DATE THE PT EXPERIENCED AN ACCIDENT WHICH CAUSED HER TO HAVE MULTIPLE FRACTURES OF THE ORBITAL BONE OF HER LEFT EYE AND A BROKEN NOSE (MEDICALLY SIGNIFICANT). SHE HAD MANY SPRAINS AND A GREAT DEAL OF PAIN, AND SHE FURTHER REPORTED THAT SHE HAS POST-CONCUSSION SYNDROME CAUSING LOSS OF BALANCE AND HEADACHES. NO TREATMENT INFO WAS REPORTED. THE ACTION TAKEN ON THE PRODUCT WAS UNK. THE OUTCOME OF THE PT'S MULTIPLE FRACTURES OF THE ORBITAL BONE, BROKEN NOSE, ACCIDENT, HEADACHES, PAIN, SPRAINS AND LOSS OF BALANCE WERE UNK. THE OUTCOME OF THE PT'S POST-CONCUSSION SYNDROME WAS REPORTED AS NOT RECOVERED/NOT RESOLVED. THE PT'S MULTIPLE FRACTURES OF THE ORBITAL BONE, BROKEN NOSE, HEADACHES, LOSS OF BALANCE, POST-CONCUSSION SYNDROME, PAIN, SPRAINS AND ACCIDENT WERE CONSIDERED TO BE NOT RELATED TO THE ORTHOTIC (DR (B)(6)'S PAIN RELIEF ORTHOTICS (PRO) FOR ARCH, WOMENS). THE REPORTER CONSIDERED THE PRODUCT NOT HELPING TO BE RELATED TO THE ORTHOTIC (DR (B)(6)'S PAIN RELIEF ORTHOTICS (PRO) FOR ARCH, WOMENS). THE ORTHOTIC (DR (B)(6)'S PAIN RELIEF ORTHOTICS (PRO) FOR ARCH, WOMENS) WAS AVAILABLE FOR THE INVESTIGATION. FOR THE ORTHOTIC (DR (B)(6)'S PAIN RELIEF ORTHOTICS (PRO) FOR ARCH, WOMENS), THE LOT NUMBER WAS NOT AVAILABLE AND THE SERIAL NUMBER WAS NOT AVAILABLE. ADDITIONAL INFO WAS NOT EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652826 DR SCHOLL'S PAIN RELIEF ORTHOTICS (PRO) FOR ARCH ORTHOSIS, CORRECTIVE SHOE (KNP) KNP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other