OWEN MUMFORD LTD WERE NOTIFIED ON THE 17TH MARCH 2010, THAT A (B) (6) PT USING A UNIFINE PEN TIP, HAD BEEN HOSPITALIZED IN ORDER TO CARRY OUT SURGERY TO REMOVE A PIECE OF NEEDLE, THAT HAD BROKEN OFF IN THE PT'S SKIN. REPORTER'S DIALOGUE: "THE CANNULA WAS BROKEN AND STAYED UNDER THE SKIN. THE PT WAS HOSPITALIZED FOR TWO DAYS FOR SURGERY TO REMOVE THE CANNULA FROM UNDER THE SKIN." PLEASE FIND ATTACHED A COPY OF THE ORIGINAL COMPLAINT FROM THE DISTRIBUTOR ((B) (4)) AND THE COMPLETED MEDICAL QUESTIONNAIRE (FORM USED BY OWEN MUMFORD TO OBTAIN BASIC FACTS OF EVENT). THIS MQ HAS BEEN COMPLETED ON BEHALF OF THE PT, BY THE PHARMACY IN (B) (4).
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Patient 1
THE UNIFINE PENTIP WAS RETURNED TO OWEN MUMFORD LTD. (WE ARE THE LEGAL MANUFACTURERS OF THIS PRODUCT). AN INITIAL EVALUATION OF THE SAMPLE HAS BEEN MADE BY OM. THE RETURNED SAMPLE AND SAMPLES FROM THE SAME BOX OF PRODUCT HAVE NOW BEEN SENT TO ARTSANA IN (B) (4) (ACTUAL MANUFACTURER). WE AWAIT FULL INVESTIGATION RESULTS FROM ARTSANA (IN ACCORDANCE WITH OUR TECHNICAL QUALITY AGREEMENT THAT THEY MUST PROVIDE US WITH A TECHNICAL EVALUATION). WE AWAIT MORE DETAILS ABOUT THE PT AND THE FACTS SURROUNDING THE EVENT FROM THE PHARMACIST IN (B) (6). WE ARE REPORTING THIS EVENT THAT TOOK PLACE IN (B) (6) AS THE SAME LOT NUMBER OF PRODUCT HAS BEEN DISTRIBUTED IN THE US.