BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIRRUS 800 BLUE

    MDR report key: 21822107 · Received April 10, 2025

    Report

    Report Number
    3015335034-2025-00001
    Event Type
    Injury
    Date Received
    April 10, 2025
    Date of Event
    February 25, 2025
    Report Date
    March 7, 2025
    Manufacturer
    IDEAL QUALITY SDN. BHD.
    Product Code
    LZA
    PMA / PMN Number
    K151750
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETAINED SAMPLES HAD BEEN SENT TO EXTERNAL INDEPENDENT LABORATORY FOR BELOW TESTING. BIOBURDEN BY SGS MALAYSIA SDN BHD. POWDER RESIDUE BY LEMBAGA GETAH MALAYSIA SDN BHD. CHEMICAL RESIDUE BY LEMBAGA GETAH MALAYSIA SDN BHD. ANIMAL IRRITATION TEST BY MAKMAL BIOSERASI & KLINIKAL FROM THE EXTERNAL TEST RESULTS, WITH ANIMAL IRRITATION TEST SHOWN THE DEVICE IS NOT AN IRRITANT FROM THE RETAINED SAMPLE TESTED, WE CONCLUDED THAT NO DEVICE PROBLEM FOUND AND NO PROBLEM DETECTED.

    Additional Manufacturer Narrative · 0

    UPON REVIEW AND VERIFICATION OF THE MANUFACTURING RECORD, WE HAVE DETERMINED THAT THERE IS ERROR ON THE MANUFACTURER NAME IN THE MDR REPORT NUMBER: MW5167609. THE MANUFACTURER NAME IS NOT KOSSAN RUBBER INDUSTRIES/KOSSAN LATEX INDUSTRIES (M) SDN BHD. THE ACTUAL MANUFACTURER FOR THE RELATED MEDICAL DEVICE IS IDEAL QUALITY SDN BHD, LOCATED AT LOT 6103, JLN HAJI ABDUL MANAN/KU8, KAWASAN PERINDUSTRIAN MERU SELATAN, 41050 KLANG, SELANGOR DARUL EHSAN. (REFER TO ATTACHMENT 5) WE HAVE REVIEWED OUR RECORD AND IN HOUSE TESTING SUCH AS GLOVE SURFACE PH TEST (REFER TO ATTACHMENT 1) HAVE BEEN CONDUCTED ON THE RETAINED SAMPLE. FROM THE INITIAL INVESTIGATION, THERE WAS NO ABNORMALITY FOUND DURING THE DEVICE HISTORY RECORD REVIEWED AND THE IN-HOUSE TESTING. THE RETAINED SAMPLES HAD BEEN SENT TO EXTERNAL INDEPENDENT LABORATORY FOR BELOW TESTING, PENDING REPORTS: BIOBURDEN TEST BY SGS MALAYSIA SDN BHD POWDER RESIDUAL AND CHEMICAL RESIDUAL TEST BY LEMBAGA GETAH MALAYSIA SDN BHD ANIMAL IRRITATION TEST BY MAKMAL BIOSERASI SDN BHD. UPON RECEIVED RESULT FROM EXTERNAL LAB, FURTHER INVESTIGATION WILL BE CARRIED OUT.

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED FRESENIUS CUSTOMER SERVICE TO REPORT THAT HIS WIFE'S HANDS ARE IRRITATED AFTER USING THE NITRILE EXAM GLOVES. PATIENT WAS ADVISED TO CONTACT THE REGISTERED NURSE SO SHE IS AWARE OF IT AND SHE CAN DECIDE WHAT OTHER GLOVES CAN BE ADDED TO THE PRESCRIPTION. THE PATIENT STATED HE WILL TALK TO THEIR RN AND THAT THIS ISSUE HAS BEEN GOING FOR ABOUT SIX WEEKS. "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)".

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED FRESENIUS CUSTOMER SERVICE TO REPORT THAT HIS WIFE'S HANDS ARE IRRITATED AFTER USING THE NITRILE EXAM GLOVES. PATIENT WAS ADVISED TO CONTACT THE REGISTERED NURSE SO SHE IS AWARE OF IT AND SHE CAN DECIDE WHAT OTHER GLOVES CAN BE ADDED TO THE PRESCRIPTION. THE PATIENT STATED HE WILL TALK TO THEIR RN AND THAT THIS ISSUE HAS BEEN GOING FOR ABOUT SIX WEEKS. "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B) (2)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103988 CIRRUS 800 BLUE NITRILE EXAM GLOVE MEDIUM LZA IDEAL QUALITY SDN. BHD. 031031103

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other