BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAST PADDING

    MDR report key: 11821197 · Received May 13, 2021

    Report

    Report Number
    1060680-2021-00003
    Event Type
    Malfunction
    Date Received
    May 13, 2021
    Date of Event
    April 26, 2021
    Report Date
    June 25, 2021
    Manufacturer
    WPT CORPORATION
    Product Code
    ITG
    UDI-DI
    50749756024384
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A SCAR WAS COMPLETED BY THE SUPPLIER; HOWEVER, NO ROOT CAUSE WAS ESTABLISHED DUE TO DEVICE NOT BEING RETURNED FOR SUPPLIER EVALUATION. PER THE SUPPLIER (BSN), "NO PRODUCT WAS REWORKED AND HAS CONFIRMED THAT NO MANUFACTURING PROCESS CHANGE HAS OCCURRED IN THE PAST TWO YEARS. ACTION WILL BE INITIATED OF PENDING ANY NEGATIVE TRENDS OR IF ADDITIONAL INFORMATION IS PROVIDED BY MONITORING THIS PRODUCT AND ISSUE." DEROYAL HAS SOLD A TOTAL OF (B)(4) UNITS OF FINISHED GOODS OF 30-321 SINCE (B)(6) 2019 TO PRESENT WITH 19 COMPLAINTS DURING THIS TIME FRAME. THERE HAS BEEN NO OTHER SIMILAR COMPLAINT USING THE SAME REASON CODE OR PART NUMBER IN THE REPORTED TIME FRAME. THE INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    FOLLOW-UP 2: IN FOLLOW-UP REPORT #1 IN SECTION G4 "PREMARKET IDENTIFICATION" IT DISPLAYED THE DEVICE AS A "COMBINATION PRODUCT", THE DEVICE IS NOT A COMBINATION PRODUCT.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE WE WERE NOT ABLE TO COMPLETE A THOROUGH INVESTIGATION. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) HAS BEEN SENT TO VENDOR IN RELATION TO THE PRODUCT ISSUE; HOWEVER, STILL WAITING FOR COMPLETION. THE INVESTIGATION IS INCOMPLETE AT THIS TIME, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ADDITIONAL INFORMATION ONCE RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    PATIENT HAD A POST OPERATION SKIN REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719892 CAST PADDING PROSTETHIC AND ORTHOTIC ACCESSORY ITG WPT CORPORATION 30-321 50749756024384

    Patients

    Seq Age Sex Outcome Treatment
    1