BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINGEMAN UROLOGY/GYN DRAPES

    MDR report key: 4232370 · Received August 27, 2014

    Report

    Report Number
    8043817-2014-00006
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Date of Event
    July 29, 2014
    Report Date
    July 31, 2014
    Manufacturer
    MICROTEK DOMINICA, S.A.
    Product Code
    KKX
    PMA / PMN Number
    EXMT, CL 2
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISPOSABLE DRAPE, PART NUMBER 1-0425, WAS NOT RETURNED; THEREFORE, NO DIRECT DEVICE ANALYSIS IS AVAILABLE. THE REVIEW CONFIRMED THE DEVICE MET ALL SPECIFICATIONS AND THE MATERIALS DO NOT CONTAIN NATURAL RUBBER LATEX. SINCE NO DEVICE WAS RETURNED FOR ANALYSIS AND NO TREATMENT RECORDS WERE PROVIDED TO THE PATIENT, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER OPENING UP A PACKAGE OF DRAPE (PART NUMBER 1-0425, PATIENT DRAPES, LINGEMAN UROLOGY / GYN DRAPES), STAFF FROM MEDLINE CONFIRMED THAT THE PATIENT HAD A SEVERE ALLERGIC REACTION AND THAT SWELLING HAD OCCURRED BECAUSE THE PATIENT HAD SENSITIVITY TO NATURAL RUBBER LATEX. NO FURTHER PATIENT INJURIES OR TREATMENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519126 LINGEMAN UROLOGY/GYN DRAPES PATIENT DRAPES KKX MICROTEK DOMINICA, S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK