Catheter Stabilization Device

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT HAD A PERMANENT FEEDING TUBE AND COULD NOT SWALLOW. THE PATIENT USED THE STATLOCK PRODUCT AND STATED THAT IT WAS A GREAT DEVICE; HOWEVER, IT SHOULD HAVE COME WITH A WARNING LABEL INDICATING NOT TO USE IT FOR MORE THAN 5 TO 6 DAYS CONSECUTIVELY BECAUSE IT CAUSED BAD SKIN BLISTERS AND RED SORES UPON REMOVAL. IT WAS FURTHER REPORTED THAT THE DEVICE POSITION HAD TO BE CHANGED TO THE OPPOSITE SIDE OF THE STOMACH TO ALLOW SKIN HEALING BEFORE RETURNING TO THE ORIGINAL SPOT. AT 89 YEARS OF AGE, SKIN HEALING WAS REPORTED TO BE SLOW, CREATING DIFFICULTY WITH DEVICE PLACEMENT. ONE WAY TO PREVENT THE GOV. FROM MAKING THEM PUT A WARNING LABEL ON IT WAS TO USE A TAPE FOR SENSITIVE SKIN TO PREVENT THOSE TERRIBLE SORES, THIS WOULD GIVE THEM 2 PRODUCTS FOR THAT SAME INJURY. A REQUEST WAS MADE FOR THE DEVELOPMENT OF A SENSITIVE TAPE THAT WOULD NOT HARM THE SKIN. IT WAS STATED THAT TIMELY ACTION WAS IMPORTANT DUE TO LIMITED LIFE EXPECTANCY AND A DESIRE FOR PAIN-FREE USE. IT WAS ALSO REPORTED THAT A WARNING LABEL ALONE WOULD NOT HAVE RESOLVED THE ISSUE, AS BAD SORES HAD ALREADY DEVELOPED ON BOTH SIDES OF THE STOMACH. AS PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2026, IT WAS REPORTED THAT PATIENT DEVELOPED SMALL TO LARGE RED SORES AND BLISTERS. THEY WENT TO (B)(6) EMERGENCY ROOM ONE TIME TO SEE WHAT COULD BE DONE TO HELP HEAL QUICKLY. THEY DID A CT SCAN TO SEE IF IT WAS ABSCESSED AND THE RESULTS WERE NEGATIVE. THEY SUGGESTED THE PATIENT USE BACITRACIN WITH GUAZE TO COVER SO IT DOESN'T GET RUBBED OFF. NO PICTURES WERE TAKEN. GRANDSON CHANGES THE DRESSINGS 2 TO 3 PER DAY AS NEEDED. PATIENT WAS NOW USING A NON ADHERENT 2 OR 3 CURAD PAD UNDER THE MIDDLE OF THE STATLOCK TO MINIMIZE RECURRING SORES TO TRY TO ELIMINATE ANY POSSIBLE SORES BUT THEY STILL HAVE TO CHANGE THE POSITION FROM ONE SIDE OF THE ABDOMEN EVERY 6 OR 7 MAX TO THE OTHER SIDE OF THE ABDOMEN IN ORDER TO CUT DOWN RECURRING SORES FROM THE TAP THEY USE WHICH WAS NOT FOR SENSITIVE SKIN. THEY SHOULD REALLY EXAMINE THE TYPE OF TAPE THAT THEY USE, THAT STUFF WAS LIKE SUPER GLUE, THEY HAD BEEN USING THAT SAME OLD TAPE FOR TOO MANY YEARS NOW AND HAVE NEVER CONSIDERED THAT SOME PEOPLE DO HAVE SENSITIVE SKIN LIKE THEY DO AND DO GET BIG SORES LIKE THEY DID THEM. AS PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2026, IT WAS REPORTED THAT A PRODUCT CATALOGUE NUMBER COULD BE PROVIDED IF REQUESTED; HOWEVER, ALL NUMBERS WERE THE SAME, AND THE TAPE WAS THE SAME ON ALL PRODUCTS. IT WAS FURTHER REPORTED THAT THE ISSUE WAS PRESENT ACROSS ALL PRODUCTS, NOT JUST ONE OR TWO. THE TAPE OR ADHESIVE WAS DESCRIBED AS BEING LIKE SUPER GLUE, AND IT WAS STATED THAT USE OF THE PRODUCT WOULD DEMONSTRATE THIS. IF PATIENT HAVE EVER WORN ONE, THEY WOULD FIND THAT OUT, TO JUST DISMISS THIS WAS NOT DOING JUSTICE TO THE CUSTOMERS WHO HAVE SENSITIVE SKIN, ONCE AGAIN A MANUFACTURER CLAIMS THERE WAS NOTHING WRONG WITH THEIR OWN PRODUCT. SELF DRIVING CARS WERE IDENTICAL PROBLEM; THEY WERE NOT STOP WHEN THEY SHOULD AND KILL MANY PEOPLE AND YET THEY SAY NOTHING WAS WRONG, YOU ARE TAKING THE SAME HIGH ROAD, NOTHING WRONG WITH OUR PRODUCT BS SAME AS THE STORE. THEY MAKE MANY DIFF LINES OF CLOTHES, IF IT DOESN'T FIT GO SOMEWHERE ELSE. AS PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2026, IT WAS REPORTED THAT THE PROBLEM WAS FOLEY STATLOCK ADHESIVE OR TAPE WAS LIKE SUPER GLUE AND NEEDED TO BE CHANGED ALA BAND-AID TYPE TAPE AND RECOMMENDED INCLUDING A WARNING LABEL STATING A MAXIMUM USE DURATION OF 6 DAYS. THE AFFECTED MATERIAL AND LOT WERE PROVIDED AS REF: FOL0102, LOT: ULQQ8156