BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDIATRIC SOFTVENT

    MDR report key: 7264217 · Received February 12, 2018

    Report

    Report Number
    9611710-2018-00016
    Event Type
    Injury
    Date Received
    February 12, 2018
    Date of Event
    January 22, 2018
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO D.1. BRAND NAME- FOLEY. UPDATED SECTIONS D.3.: MANUFACTURER. UPDATED H.10: MANUFACTURING SITE INFORMATION. UPDATED D.8: SINGLE USE DEVICE. NO ADDITIONAL DETAILS HAVE BEEN NOT PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: 1049092. MANUFACTURING SITE: 9611710.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE LAST THREE (3) PRODUCT MONITORING REVIEW'S FOR TRENDS INDICATED NO TRENDS FOR THIS ISSUE ON THIS PRODUCT. THE HISTORICAL COMPLAINT DATA FROM (B)(6) 2016 TO (B)(6) 2018 WAS REVIEWED AS IT RELATES TO REPORTS FOR PRODUCT NUMBER MM51161410P. A TOTAL OF THREE (3) COMPLAINTS, INCLUDING THIS ONE, WERE REPORTED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. NO ADDITIONAL INFORMATION PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: 1049092. MANUFACTURING SITE: 9611710.

    Additional Manufacturer Narrative · 0

    THIS EMDR IS BEING SUBMITTED AS REQUEST FOR RESUBMISSION WAS RECEIVED FROM FDA. UPDATED SECTIONS D.3. AND H.11. WITH MANUFACTURER AND MANUFACTURING SITE INFORMATION. UPDATED D.4: UNIIQUE IDENITFIER NUMBER. UPDATED D.7: SINGLE USE DEVICE. FDA REGISTRATION NUMBER. REPORTING SITE: 1049092. MANUFACTURING SITE: 9611710.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    BRAND NAME: UNO AQUALINE (CARELINE) SILICONE ELASTOMER COATED (SEC) 2-WAY STANDARD CH14. COMMON DEVICE NAME: CATHETER, UROLOGICAL. PROCODE: KOD. (B)(6). THE 510K: K896729. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A SERIOUS INJURY. ADDITIONAL DETAILS HAVE BEEN REQUESTED BUT, NOT PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ¿UPON REMOVAL OF CATHETER IT WAS NOT POSSIBLE TO DEFLATE THE RETENTION BALLOON. ASPIRATION WAS ATTEMPTED AS NORMAL, WHEN THAT WAS USELESS, IT WAS DECIDED TO CUT OFF THE VALVE TO EVACUATE THE WATER. THIS WAS ALSO UNSUCCESSFUL. THE PHYSICIAN DECIDED TO TAKE THE PATIENT INTO SURGERY WHERE THE CATHETER WAS REMOVED. METHOD NOT REVEALED TO US SO FAR.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107917 PEDIATRIC SOFTVENT TUBE, TRACHEAL (W/WO CONNECTOR) BTR UNOMEDICAL SDN BHD MM51161410P 413612R001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention