VASCLIP

Description of Event or Problem

ADD'L INFO REC'D FROM MFR 10/11/04: IN CLOSING, THE ISSUE RELATED TO REPORT NUMBER MW1032627 ARE NOT VASCLIP PRODUCT RELATED, THERE IS NO EVIDENCE OF ANY PRODUCT FAILURE IN THIS CASE, THE PRODUCT HAS NOT BEEN RETURNED AS REQUESTED TO THE COMPANY FOR ANALYSIS, AND NO SEMEN ANALYSIS RESULTS HAVE BEEN PROVIDED TO THE COMPANY AFTER NOVEMBER 12, 2003. WE BELIEVE THE REPEAT PROCEDURE IS SPECIFICALLY RELATED TO THIS SPECIFIC PHYSICIAN'S LACK OF AWARENESS AND UNDERSTANDING OF SEMEN ANALYSIS AFTER A VASECTOMY (OR VASCLIP) PROCEDURE. WITH THE SUPPORT OF AMERICAN UROLOGICAL ASSOCIATION MEMBER, WE ARE MAKING EVERY EFFORT WITHIN OUR LIMITED FINANCIAL MEANS TO SEE THAT PTS AND PHYSICIANS UNDERSTAND THE NEED FOR PROPER SEMEN ANALYSIS TESTING A VASECTOMY OR VASCLIP PROCEDURE.

Description of Event or Problem

PT HAD A RECENTLY FDA APPROVED VASCLIP INSERTED IN THEM AS AN ALTERNATIVE TO A VASECTOMY. IN APPROX AUGUST OF 2003, AFTER A SEMEN ANALYSIS SHOWED NO PRESENCE OF SPERM AND GETTING THE GO AHEAD FROM DR PT AND SPOUSE HAVING UNPROTECTED SEX. IN NOVEMBER OF 2003 PT'S SPOUSE BECAME PREGNANT AND A SUBSEQUENT SEMEN ANALYSIS SHOWED THE PRESENCE OF SPERM. ONE EVENT THAT MAY BE RELATED IS THAT IN APPROX OCTOBER OF 2003 PT HAD BLOOD IN THEIR EJACULATION. HOWEVER, AFTER AN EXAM BY DR AND A PHONE CONSULATION WITH DR, BOTH ASSURED THEM IT WAS UNRELATED TO THE VASCLIP AND PT COULD CONTINUE HAVING UNPROTECTED SEX. 2004 PT UNDERWENT A STANDARD VASECTOMY AND HAD THE VASCLIPS REMOVED.