BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKYN

    MDR report key: 5616447 · Received April 28, 2016

    Report

    Report Number
    1019632-2016-00003
    Event Type
    Injury
    Date Received
    April 28, 2016
    Date of Event
    April 25, 2016
    Report Date
    June 22, 2016
    Manufacturer
    IDS MANUFACTURING CO,.LTD
    Product Code
    NUC
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ON JUNE 9, 2016 - THREE ATTEMPTS HAVE BEEN MADE TO THE CUSTOMER (2 VIA EMAIL AND 1 VIA MAIL) TO GET ADDITIONAL DETAILS ON THE INCIDENT WITH NO RESPONSE FROM THE CUSTOMER. MANUFACTURER CAN PROVIDE NO COMMENT ON THE DEVICE AT THIS TIME WITHOUT SUCH DETAILS.

    Additional Manufacturer Narrative · 1

    JUNE 9, 2016 - THREE ATTEMPTS HAVE BEEN MADE TO THE CUSTOMER (2 VIA EMAIL AND 1 VIA MAIL) TO GET ADDITIONAL DETAILS ON THE INCIDENT WITH NO RESPONSE FROM THE CUSTOMER. MANUFACTURER CAN PROVIDE NO COMMENT ON THE DEVICE AT THIS TIME WITHOUT SUCH DETAILS. JUNE 22, 2016 - A REVIEW OF THE PRODUCT SAFETY REPORT FOR THE ORIGINAL DEVICE INDICATED THE MATERIALS IN QUESTION HAVE A VERY LOW ACUTE ORAL TOXICITY PROFILE. PRODUCT BIOCOMPATIBILITY EVALUATIONS AT THE TIME INDICATED NO ISSUE. THIS NOTICE SERVES AS THE FINAL UPDATE ON THIS REPORT ((B)(4)).

    Description of Event or Problem · 1

    CUSTOMER INQUIRED "WHAT COMPLICATIONS COULD RESULT FROM SKYN LONG LASTING LUBRICANT, THEN ORAL CONSUMPTION. INFORMATION REQUIRED AS I WAS HOSPITALIZED" (B)(6) 2016 - CUSTOMER CONTACT HAS BEEN ATTEMPTED THREE TIME (2 TIMES BY EMAIL AND 1 BY LETTER) WITH NO RESPONSE. MANUFACTURER CAN PROVIDE NO ADDITIONAL DETAIL AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER INQUIRED "WHAT COMPLICATIONS COULD RESULT FROM SKYN LONG LASTING LUBRICANT, THEN ORAL CONSUMPTION. INFORMATION REQUIRED AS I WAS HOSPITALIZED." JUNE 9, 2016 - CUSTOMER CONTACT HAS BEEN ATTEMPTED THREE TIME (2 TIMES BY EMAIL AND 1 BY LETTER) WITH NO RESPONSE. MANUFACTURER CAN PROVIDE NO ADDITIONAL DETAIL AT THIS TIME. JUNE 22, 2016 - A REVIEW OF THE PRODUCT SAFETY REPORT FOR THE ORIGINAL DEVICE INDICATED THE MATERIALS IN QUESTION HAVE A VERY LOW ACUTE ORAL TOXICITY PROFILE. PRODUCT BIOCOMPATIBILITY EVALUATIONS AT THE TIME INDICATED NO ISSUE. THIS NOTICE SERVES AS THE FINAL UPDATE ON THIS REPORT ((B)(4)).

    Description of Event or Problem · 1

    CUSTOMER INQUIRED "WHAT COMPLICATIONS COULD RESULT FROM SKYN LONG LASTING LUBRICANT, THEN ORAL CONSUMPTION. INFORMATION REQUIRED AS I WAS HOSPITALIZED"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269592 SKYN PERSONAL LUBRICANT NUC IDS MANUFACTURING CO,.LTD 15011501DR

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization