BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFINE PENTIPS

    MDR report key: 2108993 · Received May 26, 2011

    Report

    Report Number
    8021764-2011-00001
    Event Type
    Injury
    Date Received
    May 26, 2011
    Report Date
    May 25, 2011
    Manufacturer
    OWEN MUMFORD LTD.
    Product Code
    FMI
    PMA / PMN Number
    K973899
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A F/U CALL WAS MADE TO THE USER ON (B)(6) 2011 AS NO PRODUCT HAD BEEN RETURNED FOR INVESTIGATION, THE USER SAID SHE WOULD RETURN PRODUCT. ANOTHER F/U CALL WAS MADE TO THE USER ON (B)(6) 2011 AS THE PRODUCT HAS STILL NOT BEEN RECEIVED TO DATE. THE USER INFORMED US THAT THE PRODUCT HAD BEEN MAILED BACK THE DAY BEFORE ((B)(6) 2011). THE RETURNED PRODUCT WILL BE EVALUATED ON RECEIPT.

    Description of Event or Problem · 1

    OWEN MUMFORD INC WAS CONTACTED ON (B)(6) 2011 STATING THAT WHEN USING UNIFINE PENTIPS FOR AN INJECTION, THE NEEDLE BROKE OFF IN HER STOMACH AND THAT SHE HAD TO REMOVE IT WITH TWEEZERS. SHE DID NOT SEEK ANY MEDICAL ADVICE OR INTERVENTION. USER STATED THAT SHE ONLY USED THE PENTIP ONCE AND THREW THIS AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIFINE PENTIPS UNIFINE FMI OWEN MUMFORD LTD. AN3530 1003739

    Patients

    Seq Age Sex Outcome Treatment
    1 Other