Description of Event or Problem · 1
PATIENT WAS A MALE WITH NO MEDICAL PROBLEMS, ON NO MEDICINES, WHO FELL DOWN 10 STAIRS AND SUSTAINED BILATERAL PATELLA TENDON RUPTURES. I WAS THE ORTHOPAEDIC SURGEON CALLED TO EVALUATE HIM IN THE EMERGENCY DEPT. HIS INITIAL EVALUATION SHOWED INTACT SKIN AND VASCULARITY. SKELETAL SURVEY REVEALED NO OTHER INJURIES. THE DIAGNOSIS WAS CLOSED BILATERAL PATELLA TENDON RUPTURES. HE WAS TAKEN TO THE OR THE NEXT DAY AND UNDERWENT A SUCCESSFUL REPAIR OF BOTH KNEES WITHOUT COMPLICATION. A PAD FOR THE BREG POLAR CARE 500 CONTINOUS FLOW COLD THERAPY UNITS WAS PLACED ON TOP OF THE DRESSINGS FOR KNEES. -DRESSING WAS 4X4'S COVERED BY TEGADERM- AND EACH KNEE WAS PLACED IN KNEE IMMOBILIZER. AS IS OUR CUSTOM, THE NURSE IN THE RECOVERY CONNECTED THE PADS TO THE COLD THERAPY UNITS AND STARTED THE COLD THERAPY. THEY SET THE TEMPERATURE TO 40-50 F UNLESS OTHERWISE INSTRUCTED. THE PATIENT SPENT 3 UNEVENTFUL DAYS IN THE HOSPITAL. WHILE IN THE HOSPITAL, HE USED THE UNITS CONTINUOUSLY PER MY ORDERS. THE NURSES PERFORMED ROUTINE CHECKS ON THE UNITS - REFILLED THE ICE, CHECKED THE SKIN, ETC. HE WAS DISCHARGED ON POSTOP DAY 3. THE SKIN WAS INSPECTED AND THE DRESSING CHANGED BY ME. ALL LOOKED WELL. HIS INSTRUCTIONS FOR USE AT HOME WERE TO CONTINUE USING THE UNITS AS THEY WERE USED IN THE HOSPITAL FOR 3-5 DAYS MORE AS HE COULD TOLERATE, AND THEN PRN FOR SUPPLEMENTAL PAIN CONTROL. TWO WEEKS LATER, I SAW HIM IN THE OFFICE AND THE SKIN WAS DISCOLORED AND BLOTCHY. ONE KNEE HAD A LARGE FLUID COLLECTION UNDER THE SURGICAL INCISION. THIS WAS DRAINED AND LAB RESULTS INDICATED THAT IT WAS STERILE. THE STAPLES WERE NOT REMOVED BECAUSE OF CONCERN REGARDING THE SKIN AND ITS POTENTIAL TO HEAL. OVER THE NEXT 2 WEEKS, LARGE AREAS OF BOTH KNEES DEVELOPED BLACK ESCHARS OF DAMAGED SKIN. THESE AREAS EXCEEDED THE SURGICAL SITES AND THE ZONES OF INJURY. THEY WERE IN FACT DOUBLE THE ZONE OF INJURY AND CORRESPONDED TO THE CONTACT AREA OF THE PADS FOR THE COLD THERAPY UNITS. ULTIMATELY, THE PATIENT REQUIRED MULTIPLE DEBRIDEMENTS BY A PLASTIC/MICROVASCULAR SURGEON ON BOTH KNEES. I PERFORMED AN ARTHROSCOPIC DEBRIDEMENT OF BOTH KNEES SHORTLY BEFORE THE MICROVASCULAR MUSCLE GRAFT WAS TAKEN FROM THE ABDOMEN AND PLACED ON THE KNEES TO SUPPORT THE SKIN GRAFTS THAT WERE PERFORMED. HE ULTIMATELY ENDED UP WITH A 20 DEGREE EXTENSOR LAG OF BOTH KNEES BECAUSE THE PATELLA TENDONS WERE DAMAGED FROM THE THERMAL INJURY TO THE SKIN AND THE REPAIR PARTIALLY FAILED BECAUSE OF THE INJURY. HE HAS THUS FAR UNDER GONE 2 ADDITIONAL SURGERIES TO RESTORE EXTENSOR FUNCTION. IN THE FUTURE, HE MAY NEED 2-4 MORE SURGERIES, INCLUDING KNEE REPLACEMENTS. IN SHORT, THIS WAS A DEVASTATING INJURY TO THIS PATIENT, WHO WITHOUT THESE INJURIES, WAS EXPECTED TO MAKE FULL RECOVERY AND RETURN TO HIS USUAL ACTIVITIES. THE MOST CONCERNING THING TO ME IS THAT AT THE MALPRACTICE TRIAL, IT WAS BROUGHT OUT THAT BREG HAD PRIOR NOTICE OF 38 INJURIES OVER THE 12 YEAR USE OF THE UNIT. SIX AT THE LEVEL OF MY PATIENT'S. FIVE WERE REPORTED TO THE FDA. THEY MADE NO EFFORT TO INVESTIGATE THE ROLE OF THE UNIT, THEY SOUGHT NO MEDICAL OPINIONS. IN FACT, THEY DID NOT TELL THE SALES FORCE ANYTHING ABOUT THE POTENTIAL FOR INJURY. IT BECAME CLEAR AT TRIAL, THAT THEY DID NO TESTING OF HOW COLD THE PAD COULD GET. THEY TESTIFIED THAT THEY KNEW IT COULD GET AS COLD AS 36 F, BUT THAT RECOMMENDED USE FOR CONTINUOUS FLOW WAS 45-55 F. YET THE DEVICE HAS ONLY A DOT ON A PLASTIC DIAL THAT THEY INDICATED IN TRIAL IS A SAFETY DOT. BELOW THAT DOT IT IS NOT TO BE USED FOR CONTINUOUS FLOW. BUT THAT IS NOT STATED ANYWHERE IN THEIR PRODUCT INFORMATION, OR THE WARNING LEVEL. AND THERE IS NO LITERATURE THAT INDICATES THAT CONTINUOUS USE IN PATIENTS WITHOUT VASCULAR COMPROMISE POSES A RISK. THE DESIGN OF THE UNIT HAS A THERMOMETER IN THE HOSE, AND A DIAL THAT HAS "COLDER", "WARMER" ON OPPOSITE ENDS. THEY APPARENTLY KNEW THERE WAS A RISK TO PATIENTS, AND YET THEY MADE NO ATTEMPT TO CHANGE THE DEVICE TO PREVENT PATIENTS OR HEALTHCARE PROVIDERS, FROM USING IT AT A TEMPERATURE THAT MIGHT CAUSE INJURY. IN MY PATIENT, IT IS UNCLEAR WHAT THE DIAL WAS ACTUALLY SET TO WHILE AT HOME. IT APPEARS THAT MORE OF A DRESSING AND PAD BETWEEN THE COOLING PAD AND THE SKIN MIGHT HAVE HELPED. IT IS CONCERNING THAT BREG IS NOW MOVING TO SET ASIDE THE VERDICT AGAINST THEM BY NEGOTIATING A SETTLEMENT WITH PLAINTIFF. THEREBY EFFECTIVELY ERASING THE VERDICT AND THE INFORMATION THAT WAS DISCOVERED AT TRIAL.