BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDICAL ACTION INDUSTRIES INC.

    MDR report key: 8493560 · Received April 8, 2019

    Report

    Report Number
    1030451-2019-00001
    Event Type
    Injury
    Date Received
    April 8, 2019
    Date of Event
    March 7, 2019
    Report Date
    April 5, 2019
    Manufacturer
    JIANGSU GUANGDA MEDICAL MATERIAL GROUP CO., LTD.
    Product Code
    PUI
    UDI-DI
    50809160000715
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT OPENED UNDER COMPLAINT NUMBER (B)(4). A TRENDING ANALYSIS WAS PERFORMED; THERE ARE NO TRENDS RELATED TO THIS DEFECT AS PERTAINS TO THE PRODUCT. SITE WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE. THE SUPPLIER HAS BEEN NOTIFIED OF THE ISSUE.

    Description of Event or Problem · 1

    RECEIVED CUSTOMER COMPLAINT FROM DISTRIBUTOR REGARDING EVENT WHEREBY OR TOWEL PRODUCED LINT INTO SURGICAL SITE DURING AN UNIDENTIFIED PROCEDURE. PER DISTRIBUTOR, AFTER MULTIPLE GOOD-FAITH ATTEMPTS, THE END-USER REMAINS UNABLE OR UNWILLING TO PROVIDE ADDITIONAL INFORMATION REGARDING THE ALLEGED EVENT IN ORDER TO CONTRIBUTE TO FURTHER COMPLAINT INVESTIGATION. THERE ARE NO OTHER DETAILS OBTAINED AS CORRESPONDS TO THE REPORT. THE COMPLAINT ITEM IS REFERENCE NUMBER (B)(4), OR TOWEL (NON-XRAY DETECTABLE), MEDICAL ACTION INDUSTRIES BRANDED. THE COMPLAINT LOT WAS NOT REPORTED OR OBTAINED FROM END-USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283325 MEDICAL ACTION INDUSTRIES INC. OR TOWEL PUI JIANGSU GUANGDA MEDICAL MATERIAL GROUP CO., LTD. ORT400 50809160000715

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention