BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFINE PENTIPS

    MDR report key: 1700779 · Received May 26, 2010

    Report

    Report Number
    8021764-2010-00003
    Event Type
    Injury
    Date Received
    May 26, 2010
    Report Date
    May 25, 2010
    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

    (B) (6) - COMPLAINANT CONTACTED OMI TO REPORT ISSUE AND WAS REQUESTED TO RETURN NEEDLE HUB AND REMAINING PENTIPS IN HIS BOX. MEDICAL QUESTIONNAIRE SENT TO COMPLAINANT. MARCH/APRIL 2010- OMI TRIED TO CONTACT COMPLAINANT SEVERAL TIMES DURING THESE TWO MONTHS BUT COMPLAINANT DID NOT ANSWER TELEPHONE ON ANY OCCASION. ON 29TH APRIL 2010 - LETTER SENT TO COMPLAINANT TOGETHER WITH ANOTHER MEDICAL QUESTIONNAIRE. AGAIN THE COMPLAINANT HAS BEEN ASKED TO COMPLETE QUESTIONNAIRE AND RETURN PENTIPS FOR EVALUATION. AT THE DATE OF THIS REPORT, THE NEEDLE HUB HAS STILL NOT BEEN RETURNED TO OM.

    Description of Event or Problem · 1

    OWEN MUMFORD INC WAS CONTACTED ON (B) (6) 2010 BY A GENTLEMAN WHO REPORTED THAT A UNIFINE PENTIP HAD BENT WHEN ADMINISTERING INSULIN AND THAT ANOTHER WAS 'STUCK' IN HIS SKIN AND HAD TO BE REMOVED BY THE ER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIFINE PENTIPS UNIFINE FMI OWEN MUMFORD, LTD AN3530 0905752

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization INSULIN