BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC ONE

    MDR report key: 6092725 · Received November 10, 2016

    Report

    Report Number
    2246315-2016-00167
    Event Type
    Injury
    Date Received
    November 10, 2016
    Date of Event
    September 16, 2016
    Report Date
    November 1, 2016
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THIS UNSOLICITED CASE FROM UNITED STATES WAS RECEIVED ON 01-NOV-2016 FROM HEALTH CARE PROFESSIONAL (PHYSICIAN'S ASSISTANT). THIS CASE INVOLVES A (B)(6) FEMALE PATIENT WHO RECEIVED TREATMENT WITH SYNVISC ONE AND 3 DAYS AFTER RECEIVING TREATMENT EXPERIENCED PAIN AND SWELLING IN KNEE THE PATIENT RECEIVED SYNVISC ONE IN THE PAST. NO CONCOMITANT MEDICATION, MEDICAL HISTORY OR CONCURRENT CONDITION WAS REPORTED. ON (B)(6) 2016, THE PATIENT RECEIVED TREATMENT WITH INTRA-ARTICULAR SYNVISC ONE INJECTION, AT A DOSE OF 6 ML, ONCE (INDICATION, BATCH/ LOT NUMBER AND EXPIRATION DATE: NOT PROVIDED). THIS WAS THE 5TH SERIES OF SYNVISC-ONE THAT SHE HAD RECEIVED IN THE KNEE. ON (B)(6) 2016, 3 DAYS AFTER STARTING TREATMENT, THE PATIENT COMPLAINED OF PAIN AND SWELLING IN THE KNEE. THE PHYSICIAN RECOMMENDED ICE AND ELEVATION AND TO RETURN TO THE OFFICE ON (B)(6) 2016 IF UNRESOLVED. THE RETURNED TO THE OFFICE ON (B)(6) 2016 WITH SYMPTOMS STILL LINGERING. THE PATIENT RECEIVED A PREDNISONE INJECTION AT THAT TIME FROM THE PHYSICIAN'S ASSISTANT. THE ISSUE RESOLVED ITSELF OVER THE NEXT COUPLE OF DAYS. OUTCOME: RECOVERED FOR BOTH THE EVENTS. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED 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 WAS 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 WOULD CONTINUE TO MONITOR ADVERSE EVENTS TO DETERMINE IF A CAPA WAS REQUIRED. SERIOUSNESS CRITERIA: REQUIRED INTERVENTION FOR BOTH THE EVENTS. ADDITIONAL INFORMATION WAS RECEIVED ON 11-NOV-2016. GLOBAL PTC NUMBER AND PTC RESULTS WERE ADDED.

    Description of Event or Problem · 1

    THIS UNSOLICITED CASE FROM (B)(6) WAS RECEIVED ON (B)(6) 2016 FROM HEALTH CARE PROFESSIONAL (PHYSICIAN'S ASSISTANT). THIS CASE INVOLVES A (B)(6) FEMALE PATIENT WHO RECEIVED TREATMENT WITH SYNVISC ONE AND 3 DAYS AFTER RECEIVING TREATMENT EXPERIENCED PAIN AND SWELLING IN KNEE THE PATIENT RECEIVED SYNVISC ONE IN THE PAST. NO CONCOMITANT MEDICATION, MEDICAL HISTORY OR CONCURRENT CONDITION WAS REPORTED. ON (B)(6) 2016, THE PATIENT RECEIVED TREATMENT WITH INTRA-ARTICULAR SYNVISC ONE INJECTION, AT A DOSE OF 6 ML, ONCE (INDICATION, BATCH/ LOT NUMBER AND EXPIRATION DATE: NOT PROVIDED). THIS WAS THE 5TH SERIES OF SYNVISC-ONE THAT SHE HAD RECEIVED IN THE KNEE. ON (B)(6) 2016, 3 DAYS AFTER STARTING TREATMENT, THE PATIENT COMPLAINED OF PAIN AND SWELLING IN THE KNEE. THE PHYSICIAN RECOMMENDED ICE AND ELEVATION AND TO RETURN TO THE OFFICE ON 19-SEP-2016 IF UNRESOLVED. THE RETURNED TO THE OFFICE ON 19-SEP-2016 WITH SYMPTOMS STILL LINGERING. THE PATIENT RECEIVED A PREDNISONE INJECTION AT THAT TIME FROM THE PHYSICIAN'S ASSISTANT. THE ISSUE RESOLVED ITSELF OVER THE NEXT COUPLE OF DAYS. OUTCOME: RECOVERED FOR BOTH THE EVENTS A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED AND RESULTS WERE PENDING FOR THE SAME. SERIOUSNESS CRITERIA: REQUIRED INTERVENTION FOR BOTH THE EVENTS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745154 SYNVISC ONE INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention SYNVISC ONE (PREV.)