BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MX5030 TRIMO SAN

    MDR report key: 5614242 · Received April 28, 2016

    Report

    Report Number
    1216677-2016-00014
    Event Type
    Malfunction
    Date Received
    April 28, 2016
    Date of Event
    January 22, 2016
    Report Date
    March 1, 2016
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    KMJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    REFERENCE E-COMPLAINT: (B)(4). INVESTIGATION, X-INITIATED MANUFACTURER'S INVESTIGATION, X-NO SAMPLE RETURNED, REVIEW DHR, INSPECT RETURNED SAMPLES, INSPECT STOCK PRODUCT. ANALYSIS AND FINDINGS: DHR REVIEW COULD NOT BE PERFORMED AS THE SUBJECT LOT WAS NOT PROVIDED. A TWO YEAR REVIEW OF MANUFACTURING RECORDS DID NOT SHOW ANY RELATED MANUFACTURING ISSUES DURING THE LAST 2 YEARS. THERE HAVE NOT BEEN ANY RELATED PRODUCT DESIGN OR PRODUCT SPECIFICATION CHANGES IN THE LAST TWO YEARS. HISTORICAL REVIEW OF COMPLAINT FILES DID NOT SHOW ANY RELATED COMPLAINTS. A FOLLOW UP TO THE SECONDARY REPORTER, CHURCH AND DWIGHT, DID NOT YIELD ANY ADDITIONAL INFORMATION. THE COMPLAINANT HOWEVER INDICATED SHE PREVIOUSLY DID NOT HAVE ANY DISCHARGE AND HAD USED ABOUT 7 TRIMO-SAN¿ VAGINAL JELLY TUBES IN A SPAN OF 4 WEEKS PRIOR TO THE ALLEGED EVENT. THE PATIENT WAS ADVISED BY HER DOCTOR TO REDUCE THE APPLICATION OF THE TRIMO-SAN¿ VAGINAL JELLY TO TWICE A WEEK TO HELP MANAGE HER UTERINE PROLAPSE. ASSIGNABLE CAUSE COULD NOT BE DETERMINED BASED ON THE INFORMATION PROVIDED. THERE WAS NO PATIENT INJURY REPORTED. THERE HAS NOT BEEN ANY ADDITIONAL INFORMATION RECEIVED SINCE. BASED ON OVERALL COMPLAINT HISTORY, PRODUCT KNOWLEDGE, AND THE REPORTED COMPLAINT CONDITION, IT IS UNLIKELY THE REPORTED COMPLAINT CONDITION WOULD RESULT IN ANY ADVERSE EVENT. THE DISCHARGE MAY HAVE BEEN DUE TO OVER APPLICATION OF THE TRIMO-SAN¿ VAGINAL JELLY. NO FURTHER ACTIONS ARE NEEDED AT THIS TIME. COOPERSURGICAL WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR ANY ADVERSE TRENDS. CORRECTION AND/OR CORRECTIVE ACTION: NO FURTHER ACTIONS ARE NEEDED AT THIS TIME. CORRECTIVE ACTION LEVEL: 4, X-NONE. WAS THE COMPLAINT CONFIRMED? NO. REVIEW AND CLOSURE. PREVENTATIVE ACTION ACTIVITY REVIEWED. TREND AND MONITOR TO CIP.

    Description of Event or Problem · 1

    PATIENT REPORTED WHITE COTTAGE CHEESE CHUNK VAGINAL DISCHARGE AFTER 4 WEEKS OF USE TWICE WEEKLY FOR A TOTAL OF 7 TUBES. (B)(4).

    Description of Event or Problem · 1

    PATIENT REPORTED WHITE COTTAGE CHEESE CHUNK VAGINAL DISCHARGE AFTER 4 WEEKS OF USE TWICE WEEKLY FOR A TOTAL OF 7 TUBES. REFERENCE E-COMPLAINT NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272771 MX5030 TRIMO SAN MX5030 TRIMO SAN KMJ COOPERSURGICAL, INC. MX5030 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other