THE PT USED A TAMPON AND WHEN SHE WAS READY TO REMOVE IT SHE WAS UNABLE TO FIND THE TAMPON OR THE WITHDRAWAL CORD. THE PT CALLED HER GYNECOLOGIST TO CONSULT ABOUT THE PROBLEM OVER THE PHONE, AND WHEN THE TAMPON COULD NOT BE LOCATED, THE GYNECOLOGIST STATED THE TAMPON WAS PROBABLY NO LONGER IN THE PT'S VAGINA. AFTER EIGHT DAYS, THE TAMPON DISCHARGED ON ITS OWN WHILE THE PT WAS TAKING A SHOWER. THE PT REPORTED THE CORD WAS STILL ON THE TAMPON, AND THAT THE TAMPON APPEARED TO HAVE NOT EXPANDED AND WAS COVERED WITH MOLD. THE PT WENT TO THE DOCTOR AT (B)(6) BECAUSE SHE HAD FEVER AND ABDOMINAL PAIN. THE DOCTOR ALSO NOTED A DISCOLORED DISCHARGE AND PRESCRIBED METRONIDAZOLE (2X DAILY FOR ONE WEEK). NO FURTHER MEDICAL INTERVENTION WAS NOTED AND RECORDS WERE NOT VOLUNTEERED BY THE PT.
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Patient 1
EVAL COMMENTS: THE DEVICE HISTORY RECORDS FOR ASSOCIATED PRODUCTION LOTS WERE REVIEWED AND FOUND TO COMPLY WITH APPROVED SAMPLING, TESTING, AND ACCEPTANCE ACTIVITIES. RETAINED SAMPLES WERE EXAMINED TO CONFIRM WITHDRAWAL CORDS WERE PRESENT AND VISIBLE AND CUT TO THE PROPER LENGTH, AND ALL SAMPLES WERE WITHIN SPECIFICATIONS. ALL SAMPLES ALSO ABSORBED SYNGYNA TEST FLUID AND EXPANDED AS EXPECTED. ONE UNUSED SAMPLE WAS RETURNED BY THE PT FROM THE SAME BOX AS SHE HAD ORIGINALLY PURCHASED. THIS SAMPLE HAD NO VISUAL DEFECTS, THE WITHDRAWAL CORD WAS PRESENT AND MET SPECIFICATIONS, AND THE TAMPON ABSORB AND EXPANDED AS EXPECTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT HAVING BEEN REPORTED. WE CANNOT CONFIRM THAT A MFG OR OTHER QUALITY DEFECT OCCURRED.