Description of Event or Problem · 1
PATIENTS WHO RECEIVED THE SURGICALLY PLACED OB TAPE OF 2 ITEMS NUMBERS FROM JANUARY 8TH 2004 THROUGH APRIL 25TH, 2005 WERE REVIEWED BY INFECTION CONTROL. THERE WERE 126 PATIENTS WHO WERE INCLUDED IN THIS REVIEW. IT WAS REPORTED ON 9/06/05 THAT RECORDS SHOW 130 OF MENTOR OB TAPE PRODUCTS IN QUESTION WERE PURCHASED. IT WAS REPORTED SEVERAL WERE RETURNED TO THE COMPANY.OF THE 126 PATIENTS REVIEWED, 15 PATIENT WERE IDENTIFIED HAS HAVING HAD POSSIBLE ADVERSE OUTCOMES RELATED TO THE OB TAPE. COMPLICATIONS OF THE 15 IDENTIFIED PATIENTS INCLUDE: EROSION OF TRANSOBTURATOR TAPE, LABIAL ABSCESS, EROSION OF TAPE THROUGH VAGINAL MUCOSA, OBTURATOR FOSSA ABSCESS, VAGINAL VAULT ABSCESS, AND POSSIBLE SEPTICEMIA. OF THE PATIENTS WHO THOSE ITEM NUMBERSOF OB TAPE, 12% TO DATE HAVE HAD ADVERSE OUTCOMES POSSIBLY RELATED TO THE MENTOR MEDICAL PRODUCT. FROM THE REVIEW IT WAS DETERMINED, 14 OF THE 15 IDENTIFIED PATIENTS HAD UNDERWENT ADDITIONAL SURGICAL PROCEDURES TO EXCISE THE OB TAPES. OF THE 14, THREE PATIENTS HAD SURGERY MORE THAN ONCE TO EXCISE THE TAPE. ON AVERAGE, THERE WAS 9 MONTHS FROM ORIGINAL IMPLANT DATE OF THE OB TAPE PRODUCT TO TIME OF EXCISION. TWO CULTURES WERE PRODUCED FROM INFECTED OB TAPES. ONE CULTURE WAS POSITIVE FOR PREDOMINATELY GRAM-POSITIVE ORGANISMS AND THE OTHER FOR GRAM-NEGATIVE RODS. FROM THE PROVIDED LISTS, THE LAST OB TAPE IMPLANT OCCURRED ON 4/25/05.