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3"X3" STERILE PADS ASO LLC Report # 1609430
ON (B) (6) 2009, I WAS PREPARING TO CHANGE THE PAD COVERING AN AREA WHICH WAS THE RESULT OF CANCER SURGERY. I PULLED OUT A 3"X3" STERILE PAD AND DISCOVERED A FLY HAD BEEN SEALED IN THE STERILE PAD. I TOOK PICTURES ON THAT DAY AND MADE A VIDEO, TOO. I DID NOT USE ANYMORE FROM THAT BOX. I CONTACTED MY ATTORNEY AND TALKED WITH HIM. THERE HAS BEEN A LOT GOING ON IN OUR FAMILY, SO I PUT THE BOX ASIDE KNOWING I NEEDED TO FOLLOW UP ON IT AT A LATER DATE. ON FEBRUARY 3, I CONTACTED ASSOCIATED (B) (4). AND SPOKE WITH (B) (4). I GAVE HER THE NUMBERS ON THE PAD AND ALSO EMAILED PICTURES TO HER. (B) (4) FOLLOWED UP WITH A LETTER DATED 2/4/2010. SHE TOLD ME I WOULD RECEIVE A RESPONSE FROM THEIR SUPPLIER (B) (4). ON 2/11/2010, I RECEIVED A LETTER FROM ASO, LLC. THE FOLLOWING QUOTE IS FROM ASO'S LETTER: "WE HAVE STARTED INVESTIGATING FOR THE ROOT CAUSE OF YOUR FINDINGS. OUR QA DEPARTMENT IS GOING TO INVESTIGATE IF WE HAVE INVENTORY FOUND. WE WOULD LIKE TO REQUEST THAT YOU RETURN TO US THE PRODUCT FOR OUR EXAMINATION IN OUR LAB. A PRE ADDRESSED POSTAGE PAID ENVELOPE IS PROVIDED FOR YOUR CONVENIENCE. ONCE WE RECEIVE THE PRODUCT BACK, AND COMPLETE OUR INVESTIGATION, WE WILL INFORM YOU OF OUR FINDINGS." AFTER READING THE LETTER, I CALLED THE ATTORNEY GENERAL'S OFFICE IN (B) (4) AND SPOKE WITH THEIR CONSUMER GROUP. THEY SUGGESTED I CALL THE (B) (4) HEALTH DEPT. WHICH I DID AND I SPOKE WITH (B) (6). HE GAVE ME THE FDA NUMBER TO CALL IN (B) (4). I CALLED THE NUMBER AND LEFT A MESSAGE AND (B) (4)-. HE RETURNED MY CALL AND SUGGESTED THAT I FILE THIS REPORT. THE PADS WERE MADE IN (B) (4). I HAVE DEALINGS IN (B) (4) AND UNDERSTAND QUALITY CONTROL CAN BE AN ISSUE. MY CONCERN IS FOR THE PUBLIC'S SAFETY. HOW DOES A FLY GET SEALED INTO A STERILE PAD ... MORE IMPORTANTLY, IS HOW DOES A FLY GET INTO A STERILE MANUFACTURING PLANT? I CAN SEND YOU THE PICTURES AND LETTERS. I WILL NOT RESPOND TO ASO UNTIL I HEAR BACK FROM YOUR OFFICE.