BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO TOUCH PLUS PF

    MDR report key: 5494494 · Received March 11, 2016

    Report

    Report Number
    1019632-2016-00002
    Event Type
    Injury
    Date Received
    March 11, 2016
    Date of Event
    February 22, 2016
    Report Date
    June 22, 2016
    Manufacturer
    SIAM SEMPERMED CORP LTD
    Product Code
    LYY
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD. THE REVIEW INDICATED THAT THE LOT WAS IN COMPLIANCE WITH RELEASE CRITERIA. RETURNED SAMPLES WERE TESTED FOR TOTAL PROTEIN CONTENT, PH, AND POWDER RESIDUE WITH RESULTS WITHIN SPECIFICATION. FROM THE TESTING, THERE WAS NO INDICATION FOR A CAUSE OF THE CITED REACTION. PART OF THE RETURNED SAMPLES WERE SENT TO AN EXTERNAL TESTING LAB FOR ADDITIONAL TESTING. UPON COMPLETION, RESULTS WILL BE FORWARDED BACK TO ANSELL. ON 06/22/2016 UPDATE: AN EXTERNAL LAB ANALYSIS OF THE GLOVE CONFIRMED THAT THE LEVELS OF ANTI OXIDANTS AND ADDITIVES ON THE RETURNED SAMPLES WERE WITHIN SPECIFICATION IN COMPARISON TO HISTORICAL DATA ((B)(4)).

    Additional Manufacturer Narrative · 1

    SIMA SEMPERMED CORP., LTD., LOCATED IN (B)(4) CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD. THE REVIEW INDICATED THAT THE LOT WAS IN COMPLIANCE WITH RELEASE CRITERIA. RETURNED SAMPLES WERE TESTED FOR TOTAL PROTEIN CONTENT, PH, AND POWDER RESIDUE WITH RESULTS WITHIN SPECIFICATION. FROM THE TESTING, THERE WAS NO INDICATION FOR A CAUSE OF THE CITED REACTION. PART OF THE RETURNED SAMPLES WERE SENT TO AN EXTERNAL TESTING LAB FOR ADDITIONAL TESTING. UPON COMPLETION, RESULTS WILL BE FORWARDED BACK TO (B)(4).

    Description of Event or Problem · 1

    CUSTOMER INDICATED THAT BACK OF HER HANDS WERE BLEEDING AFTER WEARING THESE GLOVES. SHE HAS WORN THESE TYPE OF GLOVES FOR 35 YEARS AND NEVER HAD A PROBLEM. ONCE SHE SWITCHED TO NITRILE GLOVES HER HANDS GOT BETTER ON 06/22/2016 UPDATE: AN EXTERNAL LAB ANALYSIS OF THE GLOVE CONFIRMED THAT THE LEVELS OF ANTI OXIDANTS AND ADDITIVES ON THE RETURNED SAMPLES WERE WITHIN SPECIFICATION IN COMPARISON TO HISTORICAL DATA ((B)(4)).

    Description of Event or Problem · 1

    CUSTOMER INDICATED THAT BACK OF HER HANDS WERE BLEEDING AFTER WEARING THESE GLOVES. SHE HAS WORN THESE TYPE OF GLOVES FOR 35 YEARS AND NEVER HAD A PROBLEM. ONCE SHE SWITCHED TO NITRILE GLOVES HER HANDS GOT BETTER.

    Description of Event or Problem · 1

    CUSTOMER INDICATED THAT BACK OF HER HANDS WERE BLEEDING AFTER WEARING THESE GLOVES. SHE HAS WORN THESE TYPE OF GLOVES FOR 35 YEARS AND NEVER HAD A PROBLEM. ONCE SHE SWITCHED TO NITRILE GLOVES HER HANDS GOT BETTER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151579 MICRO TOUCH PLUS PF MICRO TOUCH PLUS PF LATEX EXAMINATION GLOVE LYY SIAM SEMPERMED CORP LTD STYLE 530 1503000977

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other