Description of Event or Problem · 1
PAIN [KNEE PAIN]. CASE NARRATIVE: INITIAL INFORMATION RECEIVED ON 25-JAN-2019 FROM UNITED STATES REGARDING AN UNSOLICITED SOCIAL VALID SERIOUS CASE RECEIVED FROM A PATIENT. THIS CASE INVOLVES A (B)(6) YEARS OLD FEMALE PATIENT WHO RECEIVED TREATMENT WITH HYLAN G-F 20, SODIUM HYALURONATE (SYNVISC) AND LATER EXPERIENCED PAIN (LATENCY: UNKNOWN). THE PATIENT'S PAST MEDICAL HISTORY, MEDICAL TREATMENT(S), VACCINATION(S) AND FAMILY HISTORY WERE NOT PROVIDED. PATIENT WAS ALLERGIC TO LANTAS. CONCOMITANT MEDICATION: INSULIN DETEMIR (LEVEMIR). ON AN UNKNOWN DATE, THE PATIENT STARTED USING RECEIVED TREATMENT WITH INTRA-ARTICULAR HYLAN G-F 20, SODIUM HYALURONATE INJECTION WITH A DOSAGE UNKNOWN (BATCH: UNKNOWN) FOR SEVERE ARTHRITIS IN BOTH KNEES. IT WAS REPORTED THAT IN THE PAST, THE INSURANCE COVERED SYNVISC INJECTIONS BY DOCTOR. LATER THEY STOPPED COVERING IT. IT WAS REPORTED THAT PATIENT HAD TRIED OTC MEDICATION, ICE PACKS, LIDOCAINE OINTMENT AND MOST OF THE TIME, BUT STILL HAD A GREAT DEAL OF PAIN. THE PATIENT WAS ASKING SHE COULD GET HELP. SHE WAS ON SSI AND SS AND REPORTED THAT SHE COULD NOT AFFORD TO PAY FOR IT HERSELF. I WANT TO BE ACTIVE AGAIN. THE PATIENT RARELY GOT OUT UNLESS IT'S FOR AN APPOINTMENT. FINAL DIAGNOSIS WAS PAIN. ACTION TAKEN: UNKNOWN. THE PATIENT WAS TREATED WITH OTC MEDICATION, ICE PACKS AND LIDOCAINE HYDROCHLORIDE (LIDOCAINE) OINTMENT. OUTCOME: UNKNOWN. SERIOUSNESS CRITERIA: MEDICALLY SIGNIFICANT. A PRODUCT TECHNICAL COMPLAINT WAS INITIATED ON 31-JAN-2019 FOR SYNVISC. BATCH NUMBER: UNKNOWN GLOBAL PTC NUMBER: (B)(4). THE PRODUCT LOT NUMBER WAS NOT PROVIDED; THEREFORE, A BATCH RECORD REVIEW IS NOT POSSIBLE. BASED ON LACK OF INFORMATION PROVIDED, NO CAPA IS REQUIRED. IT WAS THE REQUIREMENT TO REVIEW ALL FINISHED BATCH RECORDS FOR SPECIFICATION CONFORMATION PRIOR TO RELEASE. ANY OUT OF SPECIFICATION RESULT IS IDENTIFIED AND MITIGATED THROUGH THE NCR PROCESS. SANOFI GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY CONTINUOUSLY MONITORS ADVERSE EVENT REPORTS WITH OR WITHOUT LOT NUMBERS AND ASSESSES POSSIBLE ASSOCIATIONS WITH THEIR CORRESPONDING PRODUCT LOT, AS PART OF ROUTINE SURVEILLANCE EFFORT TO DETECT SAFETY SIGNALS. THIS REVIEW DID NOT INDICATE ANY SAFETY ISSUE. SANOFI WOULD CONTINUE TO MONITOR ADVERSE EVENTS TO DETERMINE IF A CAPA WAS REQUIRED. ADDITIONAL INFORMATION RECEIVED ON 31-JAN-2019. INVESTIGATION SUMMARY RECEIVED AND PTC RESULTS ADDED; TEXT AMENDED ACCORDINGLY.