BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICHOICE

    MDR report key: 6255131 · Received January 16, 2017

    Report

    Report Number
    3005555653-2017-00001
    Event Type
    Malfunction
    Date Received
    January 16, 2017
    Date of Event
    November 12, 2017
    Report Date
    January 16, 2017
    Manufacturer
    CAREMAX REHABILITATION EQUIPMENT CO., LTD
    Product Code
    IPR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    (B)(4) IS THE INITIAL IMPORTER AND PRIVATE-LABEL DISTRIBUTOR OF THE MEDICHOICE ALUMINUM CRUTCH, 131477710A. A PRODUCT RELATED PROBLEM WAS REPORTED TO AN (B)(4) EMPLOYEE ON NOVEMBER 14TH, 2016. THE (B)(4) EMPLOYEE REPORTED THAT THE PATIENT ENTERED THE ER WITH LEFT KNEE PAIN ON (B)(6) 2016. THE PATIENT REPORTED THAT HE COULD NOT PUT WEIGHT ON HIS KNEE. HE WAS DISCHARGED FROM THE ER WITH MEDICHOICE ALUMINUM CRUTCHES. THE PATIENT STATED THAT WHILE HE WAS WALKING TO HIS CAR, HE FELL AND TWISTED HIS KNEE. THE CRUTCH ALSO BROKE DURING THE INCIDENT-- IT IS NOT CLEAR FROM THE REPORT WHETHER THE CRUTCH BROKE, LEADING TO THE FALL OR WHETHER THE FALL CAUSED THE CRUTCH TO BREAK. THE PATIENT RETURNED TO THE ER WITH THE BROKEN CRUTCH BUT WAS NOR FORMALLY RE-ADMITTED. THE PATIENT STATED HE REFUSED RE-ASSESSMENT AND WAS PROVIDED WITH A NEW SET OF CRUTCHES. NO NEW INJURY WAS REPORTED NOR WAS MEDICAL INTERVENTION REQUIRED TO PREVENT PERMANENT IMPAIRMENT OR DAMAGE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38321 MEDICHOICE ALUMINUM CRUTCH IPR CAREMAX REHABILITATION EQUIPMENT CO., LTD 77710A 1607CA01A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other