Description of Event or Problem · 1
THIS UNSOLICITED DEVICE CASE FROM (B)(6) WAS RECEIVED ON (B)(6) 2015 FROM A GENERAL PRACTITIONER. THIS CASE CONCERNS A FEMALE PATIENT OF UNKNOWN AGE WHO INITIATED TREATMENT WITH SYNVISC ONE AND WAS REPORTED OF MIGHT HAVING SWELLING IN THE KNEE, HAD SEVERE PAIN OF THE KNEE AND WAS UNABLE TO WALK STAIRS. NO MEDICAL HISTORY, PAST DRUGS AND CONCOMITANT MEDICATIONS WERE REPORTED. ON AN UNSPECIFIED DATE ((B)(6) 2015), THE PATIENT INITIATED TREATMENT WITH INTRA-ARTICULAR SYNVISC ONE INJECTION, TAKEN ONCE FOR THE FIRST TIME (INJECTION IN KNEE) (DOSE, LOT/BATCH NUMBER, EXPIRATION DATE AND INDICATION NOT PROVIDED). ON AN UNKNOWN DATE AND INDICATION NOT PROVIDED). ON AN UNKNOWN DATE IN (B)(6) 2015, THE PATIENT DEVELOPED SEVERE PAIN OF THE KNEE AND MIGHT BE A SWELLING; IT WAS REPORTED THAT EXAMINATION OF THE KNEE WAS VERY DIFFICULT BECAUSE OF PRE-EXISTING ELEPHANTIASIS LIKE LEG FORM. AS A CORRECTIVE TREATMENT, THE PATIENT TOOK PAIN KILLER AND ADDITIONALLY ANTIBIOTIC THERAPY (SINCE (B)(6) 2015) WHICH CAUSED ONLY A SMALL RELIEF OF PAIN. ON (B)(6) 2015, THE PATIENT APPLIED CORTISONE AS A CORRECTIVE TREATMENT. THERE WAS NEITHER HEAT NOR REDNESS OF KNEE. ON (B)(6) 2015, FEW DAYS AFTER INITIATING SYNVISC ONE, THE PATIENT WAS NEARLY UNABLE TO WALK STAIRS. OUTCOME: UNKNOWN FOR THE EVENTS OF "MAY BE A SWELLING IN THE KNEE" AND UNABLE TO WALK STAIRS; RECOVERING/RESOLVING FOR THE EVENT OF SEVERE PAIN OF THE KNEE. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH GLOBAL PTC NUMBER: (B)(4). SERIOUSNESS CRITERIA: REQUIRED INTERVENTION (FOR THE EVENTS OF "MAY BE A SWELLING IN THE KNEE" AND "SEVERE PAIN OF THE KNEE"). FURTHER INFORMATION WAS REQUESTED.