TOTAL ABSCESSION

Additional Manufacturer Narrative

CONCLUSION: THE COMPLAINT INVESTIGATION IS INCONCLUSIVE. THE COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION. BASED ON THE INFO PROVIDED, IT APPEARS AS IF THE COMPLAINT IS USER RELATED. THE PT HAD QUESTIONED THE USE OF ALCOHOL TO FLUSH THE CATHETER. THE LABELING AND INSTRUCTIONS FOR USE BOTH STATED THE FOLLOWING WARNING: "DO NOT USE THIS CATHETER WITH ALCOHOL." THE REVIEW OF THE MANUFACTURING RECORDS VERIFIED THE POSSIBLE LOTS WERE MANUFACTURED AND RELEASED TO SPECIFICATION. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. NO FURTHER ACTION REQUIRED AT THIS TIME. FREQUENCY HAS INCREASED, BUT THE SEVERITY OF THIS EVENT IS NOT GREATER THAN USUAL. (B) (4).

Description of Event or Problem

I RECEIVED A CALL THIS AFTERNOON ON MY CELL PHONE FROM A WOMAN (B) (6) WHO CLAIMED TO HAVE HAD AN ANGIODYNAMICS DRAINAGE CATHETER "SHATTER" INSIDE OF HER. SHE HAS SOME ISSUES REGARDING HOW THE CATHETER WAS MANAGED BY HER PROVIDER AND HAD A QUESTION ABOUT THE USE OF ALCOHOL TO FLUSH THE CATHETER. I HAVE NOT ATTEMPTED TO DISCUSS OR ANSWER ANY OF HER QUESTIONS AND SUGGESTED SHE SHOULD DISCUSS THE MATTER WITH HER PHYSICIAN. HOWEVER, SHE IS ADAMANT ABOUT WANTING TO KNOW ABOUT THE CATHETER/FLUSHING WITH ALCOHOL, AND WHAT ANGIODYNAMICS TELLS THEIR CUSTOMERS. SHE DID NOT HAVE THE NAME OF THE LOCAL ANGIODYNAMICS (B) (4) REP- SO I'M NOT THE ONLY PERSON SHE HAS CALLED LOOKING FOR INFO. I LET HER KNOW I WOULD CHECK WITH OUR COMPANY AND HAVE SOMEONE CONTACT HER. I HAVE NO IDEA HOW SHE OBTAINED MY CELL PHONE NUMBER AS I HAVE NOT VISITED ANY ACCOUNTS (B) (6) TO LEAVE BUSINESS CARDS, ETC. (B) (6). I DID TRY CALLING CUSTOMER SERVICE EARLIER AND SPOKE WITH (B) (4), BUT SHE REALLY DID NOT KNOW WHAT TO DO IN THIS SITUATION AND REFERRED ME TO YOU. YOUR VOICEMAIL INDICATED THAT YOU WILL NOT BE BACK IN THE OFFICE UNTIL 2/28.