BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUREPAIR

    MDR report key: 2485570 · Received March 9, 2012

    Report

    Report Number
    1219602-2012-00044
    Event Type
    Malfunction
    Date Received
    March 9, 2012
    Report Date
    February 13, 2012
    Manufacturer
    SMITH & NEPHEW MANSFIELD MANUFACTURING SITE
    Product Code
    MQV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SMITH & NEPHEW, INC. ENDOSCOPY DIV.; IS SUBMITTING THE ENCLOSED REPORT TO COMPLY WITH 21 CFR 803, THE MDR REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY SMITH & NEPHEW INC. ENDOSCOPY DIV. WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE OF THE REPORT WAS REQUIRED BY FDA. NO PRODUCT IS BEING RETURNED FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    ONE OF OUR TRUFIT SITES RECENTLY HAD A PATIENT THAT HAD A RE-OPERATION TO REMOVE THEIR TRUFIT PLUGS DUE TO CONTINUED PAIN. UNFORTUNATELY, THE PATIENT WITHDREW CONSENT FOR THE STUDY PRIOR TO THE RE-OP AND THE INFORMATION WE CAN OBTAIN WILL BE LIMITED. THE PLUGS WERE EXPLANTED ABOUT 9 MONTHS AFTER IMPLANTATION. WE ARE NOT SURE YET IF THE SITE FEELS THIS IS RELATED TO THE DEVICE OR NOT, BUT I WILL LET YOU KNOW WHEN THEY CONFIRM. THEY HAD 2 11MM PLUGS WITH THE FOLLOWING PART/LOT NUMBERS:72200936, 50316435 & 72200936, 50351565

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUREPAIR TRUFIT CB PLUG, PURPLE, 11MM MQV SMITH & NEPHEW MANSFIELD MANUFACTURING SITE 72200936 50351565

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention