Description of Event or Problem · 1
A CUSTOMER IN THE (B)(6) REPORTED THAT A (B)(6) YEAR OLD CHILD MAY HAVE INGESTED PRESERVCYT SOLUTION AND WAS SEEKING INFO ON HOW TO HANDLE IT. HOLOGIC'S KEY ACCOUNT MANAGER (KAM) FORWARDED THE MATERIAL SAFETY DATA SHEET (MSDS) FOR PRESERVCYT SOLUTION TO HELP THEM TO CONSIDER THE MOST APPROPRIATE ACTION. THE CUSTOMER INDICATED THAT SHE DOESN'T THINK THAT THE CHILD INGESTED ANYTHING BUT ARRANGED FOR HIM TO GO TO THE HOSPITAL AS A PRECAUTION. NO ADDITIONAL INFO HAS BEEN REPORTED AT THIS TIME. US: ALTHOUGH IT IS NOT KNOWN IF THE CHILD ACTUALLY INGESTED PRESERVCYT SOLUTION, THIS IS A REPORTABLE EVENT IN THE US SINCE INGESTING PRESERVCYT SOLUTION COULD RESULT IN A POTENTIALLY SERIOUS INJURY OR ILLNESS. (B)(6): THIS IS NOT A REPORTABLE EVENT IN THE (B)(6). ACCORDING TO THE (B)(4) GUIDELINES, THIS EVENT - IF INDEED THERE WAS AN INGESTION AT ALL - WOULD CONSTITUTE ABNORMAL USE OF THE PRODUCT AND THEREFORE WOULD NOT BE REGARDED AS A REPORTABLE EVENT. OUR PRODUCT COMES WITH ALL THE NECESSARY PRECAUTIONS, LABELS AND WARNINGS AND ANY CASE OF INGESTION OF PRODUCT WOULD NOT RELATE AT ALL TO THE INTENDED USE OF THE PRODUCT. THE RESPONSIBILITY LIES WITH THE SITE/USER/CLINIC TO MONITOR HOW THEY HANDLE THE PRODUCT AND TO PERFORM ANY NECESSARY INVESTIGATIONS OR REPORTING ACCORDING TO THE SITE'S PROCEDURES AS TO HOW AN INCIDENT LIKE THAT MAY HAVE HAPPENED. OF COURSE IN A CASE LIKE THIS WHERE A TWO-YEAR OLD CHILD IS INVOLVED, RESPONSIBILITY SHOULD ALSO BE SHARED WITH THE PARENT PRESENT FOR THE PROCEDURE. IT IS A CIRCUMSTANCE ENTIRELY BEYOND HOLOGIC'S CONTROL.