BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVOX LARYTUBE 9/55

    MDR report key: 6676473 · Received June 29, 2017

    Report

    Report Number
    8032044-2017-00010
    Event Type
    Malfunction
    Date Received
    June 29, 2017
    Date of Event
    May 10, 2017
    Report Date
    May 10, 2017
    Manufacturer
    ATOS MEDICAL AB
    Product Code
    KAC
    UDI-DI
    07331791002175
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN FOLLOW UP REPORT AFTER WE RECEIVED THE DEVICE IN QUESTION FOR EVALUATION. INVESTIGATION: THE PROVOX LARYTUBE WAS VISUALLY INSPECTED AND IT IS SEEN THAT THE LARYTUBE HAS A PIECE MISSING AT THE END OF THE TUBE. CONCLUSION/ACTION: THE SILICON, WHICH THE LARYTUBE IS MADE OF, CAN RESIST EXTREMELY HIGH PULL FORCE BEFORE BEING TORN APART, BUT IF THERE IS A SMALL FRACTION FROM WHERE THE TEAR HAS STARTED THIS COULD QUITE EASILY BE LARGER. SINCE THE PATIENT HAS NOT USED THE LARYTUBE FOR MORE THAN SIX WEEKS THE SUGGESTED CAUSE OF THE DAMAGE WOULD BE THAT THE LARYTUBE HAS COME IN CONTACT WITH SOMETHING SHARP EITHER WHEN IT HAS BEEN CLEANED BY THE CUSTOMER OR IN SOME OTHER WAY. EVEN THOUGH IT IS A LOT EASIER TO PULL THE MATERIAL APART WITH A BEGINNING FRACTION COMPARED TO JUST PULLING THE MATERIAL APART, IT STILL NEEDS SOME FORCE TO CREATE THE KIND OF DAMAGE SEEN IN THIS COMPLAINT. THIS IS A NEW PHENOMENON THAT WE HAVE NOT SEEN BEFORE. ALL DEVICES ARE INSPECTED AFTER INJECTION MOLDING AND THEN MANUALLY HANDLED IN PRODUCTION BEFORE SENT TO CUSTOMER SO THIS IS DEEMED AS AN ISOLATED EVENT. CORRECTION IN THIS REPORT: THE DATE OF THIS REPORT IS CHANGED FROM 09 MAY 2017 TO 10 MAY 2017.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE DEVICE HAS NOT BEEN RETURNED FROM THE PATIENT, SO THE INVESTIGATION HAS NOT YET BEEN STARTED. HOWEVER THIS IS A NEW PHENOMENON THAT WE HAVE NOT SEEN BEFORE. ALL DEVICES ARE INSPECTED AFTER INJECTION MOLDING AND THEN MANUALLY HANDLED IN PRODUCTION BEFORE SENT TO CUSTOMER SO THIS IS DEEMED AS AN ISOLATED EVENT AND WILL BE INVESTIGATED AS SOON AS THE PRODUCT HAS BEEN RETURNED.

    Description of Event or Problem · 1

    THIS IS THE INFORMATION THAT WAS RECEIVED FROM THE ATOS MEDICAL LOCAL REPRESENTATIVE: THE PRODUCT WAS IN 6 WEEKS FROM PURCHASE, PT REMOVED ONE PM TO CLEAN AND NOTICED PIECE MISSING AT THAT TIME SHE COUGHED AND FELT SOMETHING FLY OUT (ASSUMPTION THE MISSING PIECE). ACTUAL DATE OF EVENT NOT RECALLED, ITEM BOUGHT AT THE (B)(6) CLINIC (B)(6) 2017. PT USED H2O & HYDROGEN PEROXIDE FOR CLEANING AS PER TEACHING. PT USES WATER BASED LUBRICANT TO EASE INSERTION.

    Description of Event or Problem · 1

    THIS IS THE INFORMATION THAT WAS RECEIVED FROM THE ATOS MEDICAL LOCAL REPRESENTATIVE: THE PRODUCT WAS IN 6 WEEKS FROM PURCHASE, PT REMOVED ONE PM TO CLEAN AND NOTICED PIECE MISSING AT THAT TIME SHE COUGHED AND FELT SOMETHING FLY OUT (ASSUMPTION THE MISSING PIECE). ACTUAL DATE OF EVENT NOT RECALLED, ITEM BOUGHT AT THE (B)(6) CLINIC (B)(6) 2017. PT USED H2O & HYDROGEN PEROXIDE FOR CLEANING AS PER TEACHING. PT USES WATER BASED LUBRICANT TO EASE INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456876 PROVOX LARYTUBE 9/55 LARYNGECTOMY TUBE KAC ATOS MEDICAL AB 1606018 07331791002175

    Patients

    Seq Age Sex Outcome Treatment
    1