SYNVISC
Report
- Report Number
- 2246315-2018-00696
- Event Type
- Injury
- Date Received
- October 26, 2018
- Report Date
- November 10, 2018
- Manufacturer
- GENZYME BIOSURGERY (RIDGEFIELD)
- Product Code
- MOZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- 003
Narratives
INJECTION SITE STARTED PUFFING AND SWELLING IT GOT WORST [INJECTION SITE SWELLING] ([CONDITION WORSENED]) KNEE STILL HURT [KNEE PAIN]. BAD REACTION [ADVERSE REACTION] . DRAINED THE KNEE [KNEE EFFUSION] . CASE NARRATIVE: INITIAL INFORMATION RECEIVED ON (B)(6)2018 FROM UNITED STATES REGARDING AN UNSOLICITED VALID SERIOUS CASE RECEIVED FROM A PATIENT. THIS CASE INVOLVES A 72 YEARS OLD MALE PATIENT WHO EXPERIENCED INJECTION SITE STARTED PUFFING AND SWELLING IT GOT WORST, KNEE STILL HURT , BAD REACTION AND DRAINED THE KNEE, WHILE HE WAS TREATED WITH THE USE OF MEDICAL DEVICE HYLAN G-F 20, SODIUM HYALURONATE [SYNVISC]. THE PATIENT'S PAST MEDICAL TREATMENT INCLUDED EUFLEXXA. THE PATIENT'S PAST MEDICAL HISTORY, VACCINATION(S) AND FAMILY HISTORY WERE NOT PROVIDED. ON (B)(6) 2018, THE PATIENT STARTED USING SYNVISC (HYLAN G-F 20, SODIUM HYALURONATE), INJECTION VIA INTRA-ARTICULAR ROUTE, DOSAGE UNKNOWN (LOT - UNKNOWN) FOR UNKNOWN INDICATION. ON THE SAME DAY, FEW HOURS LATER THE INJECTION, THE PATIENT DEVELOPED AN EVENT OF A SERIOUS INJECTION SITE STARTED PUFFING AND SWELLING IT GOT WORST (INJECTION SITE SWELLING) AFTER STARTING USE OF HYLAN G-F 20 AND SODIUM HYALURONATE AND THE PUFFINESS AND SWELLING GOT WORSE AGAIN (CONDITION AGGRAVATED). ON AN UNKNOWN DATE AFTER STARTING USE OF HYLAN G-F 20 AND SODIUM HYALURONATE, THE KNEE STILL HURT (ARTHRALGIA). THE PATIENT WENT BACK TO PHYSICIAN AND THE PHYSICIAN DRAINED THE KNEE (JOINT EFFUSION) AND WAS GIVEN CORTISONE SHOT WHICH HELPED FOR 2-3 DAYS. IT GOT WORSE AGAIN AND HE WAS LATER GIVEN STEROIDS WHICH DID HELP BECAUSE HIS KNEE STILL HURT AND WAS PUFF TO DATE. ICING THE SITE WON'T HELP. THE CONTINUES TO HAVE PAIN AND SWELLING DESPITE THE PHYSICIAN TAKING ABOUT 90 CC OF FLUID OFF THEN KNEE, GIVING A CORTISONE SHOT, TAKING PREDNISONE, TAKING IBUPROFEN AND NAPROXEN, USING ICE AND PERFORMING ELEVATION AND COMPRESSION. THE PATIENT REPORTED THAT WHEN THE DOCTOR WAS GETTING READY TO INJECT SYNVISC, THE DOCTOR STATED THAT THE INSURANCE REQUIRED IT INSTEAD OF EUFLEXXA AND THAT HE HAD SEEN SOME REACTIONS WITH SYNVISC. THEY PROCEEDED WITH SYNVISC BECAUSE THE DOCTOR INDICATED THAT THE REACTIONS WERE NOT THE MAJORITY OF PATIENTS. THE PATIENT WAS THAT HE STILL HAD PAIN, PUFFINESS, AND SWELLING. THE PATIENT REPORTED THAT SYNVISC AFFECTED HIS QUALITY OF LIFE SINCE DAY ONE. PATIENT STATED THAT IN THE LAST COUPLE OF DAYS THE PAIN HAD STARTED TO EASE UP BUT HE WAS STILL IN A LOT OF PAIN. PATIENT REPORTED THAT HIS REACTION TO SYNVISC HAD MADE HIM GO TO THE HOSPITAL THREE TIME SAT HIS OWN EXPENSE. HE STATED THAT THIS WAS ONLY FROM ON SYNVISC INJECTION, HE WAS SUPPOSED TO GET TWO MORE AND HE CANNOT IMAGINE WHAT WOULD HAVE HAPPENED IF HE HAD GOTTEN ANY MORE SYNVISC AS HE HD SUCH A BAD REACTION TO JUST ONE INJECTION. HE SAID HE CANNOT HELD HIS ORTHOPEDIST RESPONSIBLE AND WAS REQUESTING SANOFI TO PAY FOR HIS MEDICAL EXPENSES RELATED TO HIS REACTION TO SYNVISC INJECTION. HE STATED THAT HE WAS SERIOUSLY CONSIDERING CONSULTING AN ATTORNEY ABOUT THIS MATTER. PATIENT ALSO STATED THAT USPV HAD SENT HIM SOME PAPERWORK AND HE COULD NOT MAKE HEADS OR TAILS OF IT SO HE WOULD OT BE FILLING IT OUT AND RETURNING IT. RELEVANT LABORATORY TEST RESULTS INCLUDED: ASPIRATION JOINT - IN (B)(6) 2018: [90CC]. FINAL DIAGNOSIS WAS INJECTION SITE STARTED PUFFING AND SWELLING IT GOT WORST, DRAINED THE KNEE AND KNEE STILL HURT. THE PATIENT WAS TREATED WITH CORTISONE (CORTISONE), PREDNISONE (PREDNISONE), IBUPROFEN (IBUPROFEN) AND NAPROXEN (NAPROXEN) FOR KNEE STILL HURT, INJECTION SITE STARTED PUFFING AND SWELLING IT GOT WORST. OUTCOME- NOT RECOVERED FOR INJECTION SITE STARTED PUFFING AND SWELLING IT GOT WORST; RECOVERING FOR KNEE STILL HURT AND UNKNOWN FOR THE REST OF THE EVENTS. A PRODUCT TECHNICAL COMPLAINT WAS INITIATED ON (B)(6) 2018 FOR SYNVISC WITH GLOBAL PTC NUMBER (B)(4). THE PRODUCT LOT NUMBER WAS NOT PROVIDED; THEREFORE, A BATCH RECORD REVIEW WAS NOT POSSIBLE. BASED ON THE LACK OF INFORMATION PROVIDED, NO CAPA WAS REQUIRED. IT WAS THE REQUIREMENT TO REVIEW ALL FINISHED BATCH RECORDS FOR SPECIFICATION CONFORMANCE 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 SAFETY SURVEILLANCE EFFORT TO DETECT SAFETY SIGNALS. THIS REVIEW HAD NOT INDICATED ANY SAFETY ISSUE. SANOFI WILL CONTINUE TO MONITOR ADVERSE EVENTS TO DETERMINE IF A CAPA WAS REQUIRED. REPORTER CAUSALITY- RELATED FOR ALL EVENTS. COMPANY CAUSALITY- REPORTABLE FOR ALL EVENTS. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2018. PTC RESULTS RECEIVED AND PROCESSED. GLOBAL PTC NUMBER ADDED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2018 FROM THE CONSUMER. ADDITIONAL EVENT OF BAD REACTION WAS ADDED WITH DETAILS. OUTCOME OF KNEE STILL HURT UPDATED TO RECOVERING FROM UNKNOWN. CLINICAL COURSE UPDATED AND TEXT AMENDED ACCORDINGLY.
INJECTION SITE STARTED PUFFING AND SWELLING IT GOT WORST [INJECTION SITE SWELLING] ([CONDITION WORSENED]). KNEE STILL HURT [KNEE PAIN]. DRAINED THE KNEE [KNEE EFFUSION] . CASE NARRATIVE: INITIAL INFORMATION RECEIVED ON 16-OCT-2018 FROM UNITED STATES REGARDING AN UNSOLICITED VALID SERIOUS CASE RECEIVED FROM A PATIENT. THIS CASE INVOLVES A (B)(6) MALE PATIENT WHO EXPERIENCED INJECTION SITE STARTED PUFFING AND SWELLING IT GOT WORST, KNEE STILL HURT AND DRAINED THE KNEE, WHILE HE WAS TREATED WITH THE USE OF MEDICAL DEVICE HYLAN G-F 20, SODIUM HYALURONATE [SYNVISC]. THE PATIENT'S PAST MEDICAL TREATMENT INCLUDED EUFLEXXA. THE PATIENT'S PAST MEDICAL HISTORY, VACCINATION(S) AND FAMILY HISTORY WERE NOT PROVIDED. ON (B)(6) 2018, THE PATIENT STARTED USING SYNVISC (HYLAN G-F 20, SODIUM HYALURONATE), INJECTION VIA INTRA-ARTICULAR ROUTE, DOSAGE UNKNOWN (LOT - UNKNOWN) FOR UNKNOWN INDICATION. ON THE SAME DAY, FEW HOURS LATER THE INJECTION, THE PATIENT DEVELOPED AN EVENT OF A SERIOUS INJECTION SITE STARTED PUFFING AND SWELLING IT GOT WORST (INJECTION SITE SWELLING) AFTER STARTING USE OF HYLAN G-F 20 AND SODIUM HYALURONATE AND THE PUFFINESS AND SWELLING GOT WORSE AGAIN (CONDITION AGGRAVATED). ON AN UNKNOWN DATE AFTER STARTING USE OF HYLAN G-F 20 AND SODIUM HYALURONATE, THE KNEE STILL HURT (ARTHRALGIA). THE PATIENT WENT BACK TO PHYSICIAN AND THE PHYSICIAN DRAINED THE KNEE (JOINT EFFUSION) AND WAS GIVEN CORTISONE SHOT WHICH HELPED FOR 2-3 DAYS. IT GOT WORSE AGAIN AND HE WAS LATER GIVEN STEROIDS WHICH DID HELP BECAUSE HIS KNEE STILL HURT AND WAS PUFF TO DATE. ICING THE SITE WON'T HELP. THE CONTINUES TO HAVE PAIN AND SWELLING DESPITE THE PHYSICIAN TAKING ABOUT 90 CC OF FLUID OFF THEN KNEE, GIVING A CORTISONE SHOT, TAKING PREDNISONE, TAKING IBUPROFEN AND NAPROXEN, USING ICE AND PERFORMING ELEVATION AND COMPRESSION. THE PATIENT REPORTED THAT WHEN THE DOCTOR WAS GETTING READY TO INJECT SYNVISC, THE DOCTOR STATED THAT THE INSURANCE REQUIRED IT INSTEAD OF EUFLEXXA AND THAT HE HAD SEEN SOME REACTIONS WITH SYNVISC. THEY PROCEEDED WITH SYNVISC BECAUSE THE DOCTOR INDICATED THAT THE REACTIONS WERE NOT THE MAJORITY OF PATIENTS. THE PATIENT WAS THAT HE STILL HAD PAIN, PUFFINESS, AND SWELLING. THE PATIENT REPORTED THAT SYNVISC AFFECTED HIS QUALITY OF LIFE SINCE DAY ONE. RELEVANT LABORATORY TEST RESULTS INCLUDED: ASPIRATION JOINT - IN (B)(6) 2018: [90CC]. FINAL DIAGNOSIS WAS INJECTION SITE STARTED PUFFING AND SWELLING IT GOT WORST, DRAINED THE KNEE AND KNEE STILL HURT. THE PATIENT WAS TREATED WITH CORTISONE (CORTISONE), PREDNISONE (PREDNISONE), IBUPROFEN (IBUPROFEN) AND NAPROXEN (NAPROXEN) FOR KNEE STILL HURT, INJECTION SITE STARTED PUFFING AND SWELLING IT GOT WORST. OUTCOME- NOT RECOVERED FOR INJECTION SITE STARTED PUFFING AND SWELLING IT GOT WORST AND UNKNOWN FOR THE REST OF THE EVENTS. A PRODUCT TECHNICAL COMPLAINT WAS INITIATED ON 18-OCT-2018 FOR SYNVISC WITH (B)(4). THE PRODUCT LOT NUMBER WAS NOT PROVIDED; THEREFORE, A BATCH RECORD REVIEW WAS NOT POSSIBLE. BASED ON THE LACK OF INFORMATION PROVIDED, NO CAPA WAS REQUIRED. IT WAS THE REQUIREMENT TO REVIEW ALL FINISHED BATCH RECORDS FOR SPECIFICATION CONFORMANCE 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 SAFETY SURVEILLANCE EFFORT TO DETECT SAFETY SIGNALS. THIS REVIEW HAD NOT INDICATED ANY SAFETY ISSUE. SANOFI WILL CONTINUE TO MONITOR ADVERSE EVENTS TO DETERMINE IF A CAPA WAS REQUIRED. REPORTER CAUSALITY- RELATED FOR ALL EVENTS. COMPANY CAUSALITY- REPORTABLE FOR ALL EVENTS. ADDITIONAL INFORMATION WAS RECEIVED ON 18-OCT-2018. PTC RESULTS RECEIVED AND PROCESSED. GLOBAL PTC NUMBER ADDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 851134 | SYNVISC | MOZ | MOZ | GENZYME BIOSURGERY (RIDGEFIELD) | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |