BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDICHOICE

    MDR report key: 16994479 · Received May 24, 2023

    Report

    Report Number
    3003753847-2023-00001
    Event Type
    Injury
    Date Received
    May 24, 2023
    Date of Event
    March 15, 2023
    Report Date
    June 19, 2023
    Manufacturer
    CAREMAX REHABILITATION EQUIPMENT CO., LTD
    Product Code
    IPR
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD (DHR) OF THE PRODUCTION BATCH RECORDS WAS REVIEWED AND NO DEFECTIVE RUBBER TIPS WERE RECORDED. INSPECTION OF THE RETENTION SAMPLES FOUND NO MECHANICAL FAILURE OR QUALITY ISSUE. FROM THE EXAMINATION OF THE SAMPLE RECEIVED, IT WAS DETERMINED THAT THIS WAS AN ISOLATED INCIDENT. IN ADDITION, THE REPORTED INCIDENT HAS BEEN ENTERED IN OUR TRACKING AND TRENDING PROGRAM IN ORDER TO CONTINUOUSLY MONITOR FOR EMERGING TRENDS IN THE MARKETPLACE. OWENS & MINOR DISTRIBUTION INC. HOME-OFFICE IS THE INITIAL IMPORTER OF THIS DEVICE. A SUPPLIER CORRECTIVE ACTION (SCAR) HAS BEEN ISSUED TO THE SUPPLIER TO INVESTIGATE THIS INCIDENT AND ADVISE ON ANY CORRECTIVE ACTIONS TAKEN. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE EVENT IS AVAILABLE TO BE RETURNED. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION. OWENS & MINOR DISTRIBUTION INC. HOME-OFFICE IS THE INITIAL IMPORTER OF THIS DEVICE. A SUPPLIER CORRECTIVE ACTION (SCAR) HAS BEEN ISSUED TO THE SUPPLIER TO INVESTIGATE THIS INCIDENT AND ADVISE ON ANY CORRECTIVE ACTIONS TAKEN. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    REPORTER INDICATED THAT THEY HAD SURGERY ON (B)(6) 2023. THEY WERE PROVIDED MEDICHOICE ALUMINUM CRUTCHES, SERIAL NUMBER (B)(6). THE REPORTER IS THE PATIENT WHO IS 6"2' AND 260LBS. THE CUSTOMER INDICATED THEY WERE THE PERFECT FIT. THE RUBBER TIP OF ONE OF THE CRUTCHES BROKE DURING USE AND THEY FELL, TAKING MULTIPLE HITS TO THEIR BACK, HEAD, AND ANKLE THEY HAD SURGERY ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1897881 MEDICHOICE MEDICHOICE CRUTCHES ALUMINUM TALL IPR CAREMAX REHABILITATION EQUIPMENT CO., LTD 131477710A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other