BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEROYAL ABDOMINAL BINDER

    MDR report key: 3899034 · Received May 20, 2014

    Report

    Report Number
    3005225477-2014-00010
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 23, 2014
    Report Date
    May 19, 2014
    Manufacturer
    DEROYAL GUATEMALA
    Product Code
    FSD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: THE COMPLAINT SAMPLE WAS NOT RETURNED. THE BOM FOR THE A131067 WAS PRINTED ALONG WITH LATEX, LABELING, NPE, MSDS AND COC DUE TO A SIMILAR COMPLAINT (B)(4). NO MANUFACTURING ISSUE WAS FOUND. NO RECENT MATERIAL CHANGES HAVE BEEN MADE TO THE MATERIALS. RAW MATERIAL NUMBER 8-4001 MSDS/NPE/COC/LATEX ADDED AS WELL AS (B)(4) (SAME RAW MATERIALS JUST A DIFFERENT LENGTH TO THE (B)(4)) REPORTS/LABELING AND THE BOM ARE ATTACHED (FROM QFI 27680 ALSO REPORTED BY THIS CUSTOMER) THE COMPLAINT SAMPLES WERE RETURNED, ALL PRODUCTS ARE STAINED WITH A FOREIGN SUBSTANCE. CORRECTION: NONE REQUIRED. ROOT CAUSE ANALYSIS: UNABLE TO DETERMINE, SEVERAL FACTORS MAY CAUSE ALLERGIC REACTIONS INCLUDING PATIENTS OWN SENSITIVITY TO PRESCRIPTIONS/CHEMICALS/MATERIALS/DYES, (OTHER THAN LATEX) AS WELL AS HEAT RELATED RASHES. THE COMPLAINT SAMPLES WERE RETURNED, ALL PRODUCTS ARE STAINED WITH A FOREIGN SUBSTANCE; THIS SUBSTANCE CAN ALSO BE RASH RELATED. IT ALSO MAY NOT BE COMPATIBLE WITH THE CHEMICALS/MATERIALS/DYES IN THE PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A RASH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299557 DEROYAL ABDOMINAL BINDER BINDER, ABDOMINAL FSD DEROYAL GUATEMALA 33405645

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention