BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLV EXAM NITRILE FLEXALTOUCH PF LG

    MDR report key: 11041476 · Received December 18, 2020

    Report

    Report Number
    1423537-2020-00579
    Event Type
    Injury
    Date Received
    December 18, 2020
    Date of Event
    November 25, 2020
    Report Date
    December 18, 2020
    Manufacturer
    SGP01 SINGAPORE
    Product Code
    LZC
    UDI-DI
    10885380157363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON SUPPLIER INVESTIGATION, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED, AS THE LOT NUMBER WAS NOT PROVIDED. NO SAMPLE WAS RETURNED FOR THE INVESTIGATION. THERE IS NO OCCURRENCE REPORTED IN THE PAST 12 MONTHS. NO CHANGES HAVE BEEN MADE TO THE MANUFACTURING PROCESS AND PRODUCT FORMULATION OF THE AFFECTED PRODUCT. SUPPLIER CONFIRMED THEIR PRODUCT FORMULATION DOES NOT CONTAIN ANY DIALKYLTHIOUREAS. SUPPLIER INITIATED PH TEST ON THE RETAINED SAMPLES FROM A RANDOM GOOD SHIPMENT. THE PH TEST HAD BEEN CONDUCTED ON 3 PIECES OF RETAINED SAMPLES TO DETERMINE THE PH VALUE OF THE GLOVES. THE PH TEST RESULTS SHOW THAT THE GLOVES¿ PH VALUES ARE WITHIN SPECIFICATION. SUPPLIER HAD REVIEWED THE BIOCOMPATIBILITY TEST REPORT (ISO (B)(4) ANIMAL IRRITATION TEST AND DERMAL SENSITIZATION ASSAY TEST) FOR THE AFFECTED PRODUCT. THE TESTS CONCLUDED THAT THE GLOVES WERE NON-IRRITANT AND NON-SENSITIZING. BASED ON THE INVESTIGATION AND ANALYSIS MADE ON THE RETAINED SAMPLES, NO ABNORMALITY WAS FOUND THAT COULD LEAD TO THE REPORTED ISSUE. ALL TESTING CONDUCTED PROVED THAT THE GLOVES CONFORM TO THE QUALITY REQUIREMENTS. THE ROOT CAUSE COULD NOT BE DETERMINED FOR THIS CASE. NO ACTION WILL BE TAKEN AT THIS TIME, WE WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    BASED ON INFORMATION RECEIVED BY THE CUSTOMER, THE PATIENT REPORTEDLY HAD AN ALLERGIC REACTION TO DIALKYLTHIOREAS. HOSPITAL REPORTED THE INFORMATION TO SEE IF CARDINAL HEALTH GLOVE 88RT04L CONTAINS THIS PRODUCT. THE PATIENT REPORTEDLY WAS GIVEN 50MG OF BENADRYL VIA IV WHILE INTUBATED. THE PATIENT ALLEGEDLY EXPERIENCED HIVES ON THE TORSO AFTER HAVING BEEN TOUCHED BY THE GLOVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1503624 GLV EXAM NITRILE FLEXALTOUCH PF LG PATIENT EXAMINATION GLOVE, SPECIALTY LZC SGP01 SINGAPORE 88RT04L UNKNOWN 10885380157363

    Patients

    Seq Age Sex Outcome Treatment
    1 Other