BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC ONE (SYNVISC ONE)

    MDR report key: 6596509 · Received May 29, 2017

    Report

    Report Number
    2246315-2017-00090
    Event Type
    Injury
    Date Received
    May 29, 2017
    Report Date
    May 17, 2017
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THIS UNSOLICITED CASE FROM (B)(6) WAS RECEIVED ON 17-MAY-2017 FROM A HEALTH CARE PROFESSIONAL. THIS CASE CONCERNS A MALE PATIENT (AGE UNSPECIFIED) WHO RECEIVED TREATMENT WITH SYNVISC ONE INJECTION AND AFTER UNKNOWN LATENCY PATIENT HAD SWELLING OF KNEE AFTER INJECTION. NO RELEVANT MEDICAL HISTORY, CONCOMITANT MEDICATIONS AND PAST DRUG WERE REPORTED. ON AN UNKNOWN DATE, THE PATIENT RECEIVED TREATMENT WITH INTRA-ARTICULAR SYNVISC ONE INJECTION (LOT NUMBER: 6RSL022ZA EXPIRATION DATE: 31-MY-2019). ON AN UNSPECIFIED DATE, AFTER UNKNOWN LATENCY OF RECEIVING THE INJECTION PATIENT HAD SWELLING OF KNEE AFTER INJECTION. PATIENT HAD TO GO TO THE HOSPITAL TO HAVE ARTHROSCOPE. THE PHYSICIAN WAS ALERTED BY FELLOW SURGEONS THAT THERE MIGHT BE A PROBLEM WITH SYNVISC ONE. PATIENT TOLD CLINIC THAT IT TOOK THREE WEEKS FOR THE SWELLING TO GO DOWN. THE CLINIC HAD QUARANTINED BATCH 6RSL022ZA FOR TIME BEING. CORRECTIVE TREATMENT: ARTHROSCOPE. OUTCOME: RECOVERING. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH GLOBAL PTC NUMBER (B)(4)(RESULTS WERE PENDING). SERIOUSNESS CRITERION: REQUIRED INTERVENTION. NO FURTHER INFORMATION WAS PROVIDED. CONSENT TO CONTACT FOR FOLLOW-UP WAS GIVEN.

    Description of Event or Problem · 1

    THIS UNSOLICITED CASE FROM (B)(6) WAS RECEIVED ON 17-MAY-2017 FROM A HEALTH CARE PROFESSIONAL. THIS CASE CONCERNS A MALE PATIENT (AGE UNSPECIFIED) WHO RECEIVED TREATMENT WITH SYNVISC ONE INJECTION AND AFTER UNKNOWN LATENCY PATIENT HAD SWELLING OF KNEE AFTER INJECTION. NO RELEVANT MEDICAL HISTORY, CONCOMITANT MEDICATIONS AND PAST DRUG WERE REPORTED. ON AN UNKNOWN DATE, THE PATIENT RECEIVED TREATMENT WITH INTRA-ARTICULAR SYNVISC ONE INJECTION (LOT NUMBER: 6RSL022ZA EXPIRATION DATE: 31-MAY-2019). ON AN UNSPECIFIED DATE, AFTER UNKNOWN LATENCY OF RECEIVING THE INJECTION PATIENT HAD SWELLING OF KNEE AFTER INJECTION. PATIENT HAD TO GO TO THE HOSPITAL TO HAVE ARTHROSCOPE. THE PHYSICIAN WAS ALERTED BY FELLOW SURGEONS THAT THERE MIGHT BE A PROBLEM WITH SYNVISC ONE. PATIENT TOLD CLINIC THAT IT TOOK THREE WEEKS FOR THE SWELLING TO GO DOWN. THE CLINIC HAD QUARANTINED BATCH 6RSL022ZA FOR TIME BEING. CORRECTIVE TREATMENT: ARTHROSCOPE. OUTCOME: RECOVERING. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH (B)(4). THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT # 6RSL022ZA EXPIRATION DATE (05/2019) WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. BASED ON THE LOT # BATCH RECORD REVIEW & LOT # FREQUENCY ANALYSIS FOR LOT 6RSL022ZA NO CAPA WAS REQUIRED. SANOFI GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY CONTINUOUSLY MONITORED ADVERSE EVENT REPORTS WITH OR WITHOUT LOT NUMBERS, AND ASSESSED 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. AS OF 23-MAY-2017, THERE ARE A TOTAL OF 8 COMPLAINTS ON FILE FOR LOT # 6RSL022Z AND ALL RELATED SUBLOTS: 3 COMPLAINTS ARE ON FILE FOR LOT# 6RSL022Z (1) LABELING ISSUE (BAR CODE LABEL) AND 2 ADVERSE EVENT REPORTS. FIVE (5) COMPLAINTS ARE ON FILE FOR LOT# 6RSL022ZA: 5 ADVERSE EVENT REPORTS. SANOFI WILL CONTINUE TO MONITOR COMPLAINTS TO DETERMINE IF A CAPA WAS REQUIRED. SERIOUSNESS CRITERION: REQUIRED INTERVENTION. FOLLOW UP WAS RECEIVED ON 18-MAY-2017 FROM A DOCTOR. IT WAS REPORTED THAT ANOTHER PRACTICE IN (B)(6) HAD JUST REPORTED CASES OF SWELLING WITH SYNVISC ONE BUT DID NOT HAVE THE BATCH DETAILS AVAILABLE. HOWEVER, WHEN THEY CHECKED THE FOLLOWING STOCK THEY HAD ON HAND, IT WAS THE SAME AS THE BATCH MENTIONED. ADDITIONAL INFORMATION WAS RECEIVED ON 23-MAY-2017. PTC RESULTS WERE ADDED. TEXT WAS AMENDED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377460 SYNVISC ONE (SYNVISC ONE) INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) 6RSL022ZA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention