Description of Event or Problem · 1
ON (B)(6) 2020, I PICKED UP A PRESCRIPTION FROM (B)(6) PHARMACY FOR ABBOTT FREESTYLE 28-GAUGE STERILE LANCETS (MFG. BY ABBOTT DIABETES CARE, INC.). A FEW DAYS LATER, AFTER ALREADY USING A FEW OF THE LANCETS, I DISCOVERED A METAL SCREW INSIDE THE BOX OF LANCETS, WHICH I FEEL MADE THE LANCETS CONTAMINATED, SO I DIDN'T USE ANY MORE OF THEM. I SENT A LETTER TO ABBOTT DIABETES CARE ON (B)(6) 2020 ALONG WITH PICTURES OF THE PRODUCT, THE BOX, AND THE SCREW THAT WAS IN THE BOX AND NEVER RECEIVED ANY RESPONSE FROM THEM. ON (B)(6) 2020, I SENT A 2ND LETTER BY CERTIFIED MAIL TO ABBOTT DIABETES WITH THE SAME ATTACHMENTS AS PREVIOUS LETTER. ON (B)(6) 2020, I RECEIVED A TELEPHONE CALL FROM ABBOTT, WHICH WAS 4-1/2 MONTHS AFTER SENDING THE FIRST LETTER. HER CONCERN WAS WHETHER OR NOT I HAD ANY MEDICAL ISSUES DUE TO THIS INCIDENT AND WANTED TO KNOW IF I STILL HAD THE BOX THE LANCETS AND SCREW WERE IN. SHE WANTED ME TO SEND THEM THE BOX, AND YET I NEVER RECEIVED AN APOLOGY OR EXPLANATION AS TO HOW THIS HAPPENED. ABBOTT DID SEND ME A REPLACEMENT BOX OF LANCETS WITHIN A FEW DAYS AFTER THE TELEPHONE CALL. I DO STILL HAVE THE BOX OF LANCETS AND THE SCREW THAT WAS IN IT, BUT I AM NOT SENDING ANY OF IT BACK TO THEM UNTIL SOME LEGAL AUTHORITY ADVISES ME TO DO SO. I FILED A COMPLAINT WITH THE US CONSUMER PRODUCT SAFETY COMMISSION ON (B)(6) 2020, BUT THEY HAVE JUST INFORMED ME THAT I NEED TO FILE MY COMPLAINT WITH THE US FDA. ABBOTT DIABETES CARE, INC., ASSIGNED THIS CASE # (B)(4). FDA SAFETY REPORT ID# (B)(4).