BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURG PAT XRAY 1/2X1 -200

    MDR report key: 8861284 · Received August 5, 2019

    Report

    Report Number
    1226348-2019-00312
    Event Type
    Malfunction
    Date Received
    August 5, 2019
    Report Date
    July 19, 2019
    Manufacturer
    RAYNHAM
    Product Code
    HBA
    PMA / PMN Number
    K880402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UDI (B)(4). THE COMPLAINT SAMPLE WAS NOT RETURNED TO CODMAN, THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. DEVICE HISTORY RECORDS (DHRS) WERE REVIEWED AND NO ANOMALIES WERE FOUND. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. COMPLAINT WILL BE CLOSED AS 'NO COMPLAINT SAMPLE RETURNED TO CODMAN FOR EVALUATION'. IF THE COMPLAINT SAMPLE BECOMES AVAILABLE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 801402 SURG PAT XRAY 1/2 X 1 -200 PATTIES WITH AN EXTRA ONE AND WITHOUT A STRING. THIS WAS AN OUT-OF-BOX FAILURE. THERE WAS NO KNOWN DELAY AND PATIENT WAS NOT PREPPED FOR A SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654241 SURG PAT XRAY 1/2X1 -200 SURGICAL PATTIES HBA RAYNHAM J2248R

    Patients

    Seq Age Sex Outcome Treatment
    1