BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMO SAN

    MDR report key: 6581175 · Received May 22, 2017

    Report

    Report Number
    1216677-2017-00037
    Event Type
    Malfunction
    Date Received
    May 22, 2017
    Date of Event
    April 26, 2017
    Report Date
    June 12, 2017
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGD
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. THE DEVICE INVOLVED IN THE COMPLAINT WILL NOT BE RETURNED BY THE PATIENT FOR EVALUATION. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW UP REPORT WILL BE FILED. (B)(4). UPDATE 06/12/2017. INVESTIGATION: NO SAMPLE RETURNED. ANALYSIS AND FINDINGS: AN EVALUATION OF THE COMPLAINANT SAMPLE COULD NOT BE CONDUCTED SINCE IT WILL NOT BE RETURNED. THE TRIMOSAN TUBE IS PURCHASED FROM A SUPPLIER AND IS PACKAGED AT COOPERSURGICAL WITH THE APPLICATOR TO FORM PART NUMBER MX5030. FOR THIS COMPLAINT, A LOT NUMBER WAS NOT FURNISHED. A REVIEW OF TWO YEAR COMPLAINT HISTORY SHOWS NO COMPLAINTS FOR THIS ISSUE. THE TRIMOSAN TUBE HAS A SAFETY SEAL AT THE DISPENSING POINT AND THE SEAL IS BROKEN BY USING THE POINTED INTERIOR OF THE CAP. COOPERSURGICAL HAS ATTEMPTED TO CONTACT THE COMPLAINANT MULTIPLE TIMES, HOWEVER, THERE HAS BEEN NO RESPONSE. THUS, FURTHER INFORMATION IS NOT AVAILABLE. REGARDING THE SAFETY SEAL ON THE TRIMOSAN TUBE, THERE HAVE BEEN NO DRAWING CHANGES SINCE 2012 AND TRIMOSAN HAS AN EXPIRATION DATE OF ONLY TWO YEARS. WITHOUT THE SAMPLE, IT IS NOT CLEAR WHAT MAY HAVE CAUSED THE DIFFICULTY IN BREAKING THE SEAL. ALSO, SINCE FURTHER INFORMATION IS NOT AVAILABLE, IT IS NOT CLEAR WHAT MAY HAVE CAUSED THE NICKEL SIZED BLOOD. WILL CONTINUE TO MONITOR FOR TRENDING. CORRECTION AND/OR CORRECTIVE ACTION: THIS COMPLAINT CONDITION IS A LEVEL 4 AND DOES NOT POSE ANY PATIENT RISK. COMPLAINTS OF THIS NATURE WILL BE ADDRESSED BY THE CIP INITIATIVE AT COOPERSURGICAL. NO FURTHER ACTION IS NEEDED AT THIS TIME. HOWEVER, THIS COMPLAINT WILL BE REOPENED AND RE-EVALUATED SHOULD THE SAMPLES BE RETURNED. ALL COMPLAINTS IN THE CIP PROGRAM ARE TRENDED AND REVIEWED ON A QUARTERLY BASIS BY MANAGEMENT AT COOPERSURGICAL TO DETERMINE APPROPRIATE COURSE OF ACTION. PRODUCT WILL NOT BE RETURNED.

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. THE DEVICE INVOLVED IN THE COMPLAINT WILL NOT BE RETURNED BY THE PATIENT FOR EVALUATION. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW UP REPORT WILL BE FILED. (B)(4). PRODUCT WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    (B)(4). "YESTERDAY MORNING, TUESDAY, I HAD SURPRISING DIFFICULTY OPENING THE FIRST TRIMO-SAN TUBE. I TRIED A SECOND TUBE WHICH WAS EQUALLY DIFFICULT, I FINALLY WAS ABLE TO PIERCE THE END OF ONE OF THE TUBES. I THEN USED THE TUBE AND WAS ABLE TO COVER THE INFLATOBALL AND INSERT AS USUAL. BUT, WHEN I REMOVED THE INFLATOBALL TUESDAY EVENING, I WAS SHOCKED TO SEE BLOOD - A NICKEL' SIZE AMOUNT OF SLIGHTLY DARK, SLIGHTLY THICKER LOOKING BLOOD ON THE BALL ALONG WITH A COUPLE OF OTHER LIGHTER SMEARS OF BLOOD. BUT I AM STILL CONCERNED THAT THE SURPRISING EFFORT IT TOOK TO PIERCE THE END OF THE TUBE LOOSENED OR BROKE OFF A TINY PIECE OF THE METAL' THAT COVERS THE TUBE OPENING."

    Description of Event or Problem · 1

    (B)(4)."YESTERDAY MORNING, TUESDAY, I HAD SURPRISING DIFFICULTY OPENING THE FIRST TRIMO-SAN TUBE. I TRIED A SECOND TUBE WHICH WAS EQUALLY DIFFICULT I FINALLY WAS ABLE TO PIERCE THE END OF ONE OF THE TUBES. I THEN USED THE TUBE AND WAS ABLE TO COVER THE INFLATOBALL AND INSERT AS USUAL. BUT, WHEN I REMOVED THE INFLATOBALL TUESDAY EVENING, I WAS SHOCKED TO SEE BLOOD - A NICKEL' SIZE AMOUNT OF SLIGHTLY DARK, SLIGHTLY THICKER LOOKING BLOOD ON THE BALL ALONG WITH A COUPLE OF OTHER LIGHTER SMEARS OF BLOOD. BUT I AM STILL CONCERNED THAT THE SURPRISING EFFORT IT TOOK TO PIERCE THE END OF THE TUBE LOOSENED OR BROKE OFF A TINY PIECE OF THE METAL' THAT COVERS THE TUBE OPENING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364524 TRIMO SAN TRIMO SAN HGD COOPERSURGICAL, INC. MXAPP UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other